Drug and Alcohol Findings home page in a new window EFFECTIVENESS BANK BULLETIN 20 July 2009

The entries below are our accounts of documents collected by Drug and Alcohol Findings as relevant to improving outcomes from drug or alcohol interventions in the UK. The original documents were not published by Findings; click on the Titles to obtain copies. Free reprints may also be available from the authors. If displayed, click prepared e-mail to adapt the pre-prepared e-mail message or compose your own message. The Summary is intended to convey the findings and views expressed in the document. Below may be a commentary from Drug and Alcohol Findings.


Opiate-blocking implants reduce post-detoxification relapse ...

Unique head-to-head trial of opiate blocker versus substitute drug ...

Foil packs extend harm reduction reach of needle exchanges ...

School and family prevention programmes benefit high risk youngsters most ...

Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial.

Kunøe N., Lobmaier P., Vederhus J.K. et al.
British Journal of Psychiatry: 2009, 194, p. 541–546.
Unable to obtain a copy by clicking title? Try asking the author for a reprint by adapting this prepared e-mail or by writing to Dr KunKunøe at nikolaj.kunoe@medisin.uio.no.

In the first randomised trial, implants which block opiate-type drugs for months helped heroin addicts in Norway avoid relapse after detoxification. If these or allied products gain a UK licence, they could help pave the way to abstinence for the minority of suitable addicts.

Summary Naltrexone is a medication which blocks the effects of heroin and other opiate-type drugs. Its considerable potential in helping to prevent post-detoxification relapse has not been realised because patients generally refuse to take it or quickly discontinue. However, these limitations apply to the oral formulation which has be taken daily. Longer-lasting formulations in the form of a depot injection or an implant inserted under the skin avoid the need to take the medication daily. This is the first randomised trial of an implant whose opiate-blocking effects last for about six months.

Over 18 months from January 2006, staff at inpatient drug clinics in south-eastern Norway invited opiate-dependent patients on abstinenceľoriented programmes to participate in the study. Patients who agreed were contacted by researchers at the end of their detoxification or residential treatment. The 56 who joined the study were told that for the first six months they would be randomly allocated to the implant or to usual aftercare arrangements, but that then all would be offered (re)implantation. Typically they were male injectors in their 30s who had used heroin for on average seven years; nearly all also used other drugs.

Average proportion days using opiate-type drugs

Three of the implant group left the clinic before they could be implanted and another three had the implants removed. All but three Follow-up results for these patients were assumed to be the same as the last time they were assessed, presumably the initial baseline assessment. of the surviving (there were two deaths) patients were reassessed six months later. The main analysis included all the patients whether or not they had received or retained their implants. Over the six months of the follow-up, usual-care patients recalled using opiate-type drugs on average on 97 days, the implant group on just 37 days chart. This differential remained in the last month of the follow-up, when the corresponding figures were 17 and six days, a statistically significant difference. Average frequency of use was also significantly higher among the usual-care patients. At the six-month follow-up assessment, 18 out of 27 usual-care patients but just 9 of the 29 implant patients continued to meet criteria for opioid dependence. In line with this, implant patients were much less likely to experience craving. Nevertheless, during the study over half (18 of 29) tried opioids at least once.

In the last month of the follow-up, implant patients scored significantly lower on an index of multiple drug use and injected less often, but there were no significant differences in drinking or use of non-opioid drugs. Over the follow-up, usual-care patients averaged significantly more repeat detoxifications (0.71 versus 0.21); there were no significant differences in outpatient treatment attendance or use of aftercare services. By the end of the follow-up, implant patients expressed greater satisfaction with their lives but there were no significant differences in levels of depression, work, or criminal activity.

One patient in the implant group reported three non-fatal overdoses (there were four in the usual-care group) while using combinations of opioids, amphetamines and benzodiazepines. Three had implants removed due to infection, discomfort or side-effects. In another two, wound-opening required antibiotic treatment, and three had allergic reactions treated with antihistamines. The single death among patients allocated to implants was an overdose prior to implantation. There was also one overdose death among the usual-care patients.

The authors concluded that naltrexone implants safely and significantly reduced opioid use in a motivated population of patients.

Findings logo commentary In the UK, neither implants nor depot injections of naltrexone have been licensed for medical use; they can still be (and have been; 1 2 Revill J. "A Comparative study of the protective benefits of oral and implanted naltrexone in a British NHS general practice." Abstracts from 7th International Conference 2002. Stapleford Trust. 3 Daly M. "Implant progress blocked." Druglink: September/October 2004, p. 12–13. 4) used, but patient and doctor have to accept the added responsibility of a product which has not yet been shown to meet the safety and efficacy requirements involved in licensing.

As with oral naltrexone, the main limitation of the treatment is its acceptability to patients. In Norway acceptability will have been heightened by restricted access to substitute prescribing programmes, particularly for people unwilling to contract to forgo not just heroin, but persistent substance use of any kind. Nevertheless, recruitment to the study seems to have been slow. Just 56 out of 667 assessed for the study were recruited over 18 months at two (or possibly more) clinics, a throughput of at best just over two a month per clinic. The 56 out of 667 patients who joined the study were probably unusually highly motivated Most of the 611 patients who did not join the study did not complete their initial treatments or were planning to continue care at other clinics or in maintenance treatments. Another 131 who might have joined the study simply refused. The 56 left had completed the initial treatment and were prepared to countenance a relatively untried follow-on procedure which (barring surgical or self-removal) blocked opiate effects for six months. As the authors pointed out, the absence of self-removal attempts and the high retention rate seem further signs of high motivation and compliance. to sustain abstinence from opiates, yet over half the implant patients tried resuming opiate use. Though the implant was expected to render such use futile, repeated use did happen: on average the 12 of 23 followed-up implant patients who used opioids had used these drugs on about 38 days out of the roughly 180 days of the study, figures were skewed by some very frequent users. This degree of persistence seems incompatible with the implant having among these patients totally eliminated opiate-type effects.

The reduction in multiple drug use seems to have been mainly due to the effect on opiate use, since drinking and use of other drugs were not significantly affected. As this study shows, implants and depot injections do not guarantee abstinence. Implants can be removed and both these and depot injections can be sidestepped by turning to non-opiate drugs (as may have happened in Australia) or overridden by very high doses of opiate-type drugs, attempts which risk overdose.

The implants were compared against relatively weak The usual aftercare against which the implants were compared does not appear to have been a continued service from the clinics, but external counselling and other services which (if necessary with help from the clinics) patients would have had to arrange for themselves. aftercare arrangements; more active and structured aftercare (for example, regular monitoring, continued well organised care from the initial service, or active referral) might have narrowed the differences between the groups. However, highly motivated patients and imperfect aftercare arrangements probably reflect the conditions in which implants would be deployed in normal practice, Where the study departed most from normal practice was in holding out to the usual-care group the prospect of an implant in six months time, a prospect which (as the authors commented) may have helped keep them in the study and possibly also given them an incentive not to become so dependent that implantation would be ruled out. as does the fact that patients knew whether they had an active implant; unlike some other studies, there was no placebo comparison group.

Of the 26 patients who were implanted, eight (nearly 1 in 3) experienced complications which led three to have the implant removed. One other potential problem is that implants impede opiate-based pain relief. To cater for this, participants were given a card to carry which specified the presence of a naltrexone implant, its expected duration, possible pain relief options, and contact details for study staff. Without this (as reported in Australia) hospital staff sometimes make futile attempts to relieve pain using opiate-type medications. The same report of hospital admissions after implantation identified severe withdrawal symptoms after rapid detoxification to the point where hospitalisation was required. Long-acting naltrexone means one effective way of relieving these symptoms (using opiate-type drugs) is denied to the patient, though others Patients can be sedated (in an intensive care unit if necessary) and given clonidine, octreotide and other anti-withdrawal drugs while the objective withdrawal symptoms decline, as they do within hours. Personal communication from Dr Colin Brewer August 2012. remain.

Norwegian prison study

Other related reports from Norway have also been analysed by Findings. Two concerned a sister study from the same research team of prisoners dependent on opiates before their sentence who in their final month in prison were randomly allocated to naltrexone implants or methadone maintenance to promote continuity of treatment on release and avoid relapse. One focused on the acceptability of the attempt to randomly allocate prisoners, while a second focused on drug use and other outcomes after six months.

The prison study found that inmates refused treatment usually because they misjudged their ability to maintain abstinence on release. At the same time this misplaced confidence and features of the prison environment impeded treatment entry. Motivating inmates to accept treatment in prison involves cooperation between prison health services, criminal justice staff and (to ensure continuity and support on release) community treatment providers, as well as researchers if the treatment offer is part of a study. For methadone in particular, continuity often could not be arranged. Unless removed, naltrexone implants automatically continued on release, but fewer inmates were prepared to go through with this treatment.

Despite the fact that 17 of the 44 patients did not initiate treatment in prison, compared to the six months before their imprisonment, on average in the six months after release frequency of use of heroin and illicit benzodiazepines had significantly declined. From using heroin nearly every day before prison, after release use was down to 15–20 days a month. Days per month on which crimes were committed also fell significantly by 4–5 days a month to on average every other day. Neither on these measures nor on the days the former prisoners 'survived' before relapsing to heroin use were there any significant differences between prisoners allocated to methadone versus those allocated to naltrexone.

Data from implanted patients in these and another Norwegian study have been amalgamated in a report which assessed the degree to which the implants actually did block the effects of opiate-type drugs and prevent opiate use. Drawing on data from the same patients, a further report assessed how many would continue the treatment by having a second implant after six months.

Amalgamated findings from Norway

From all these Norwegian reports it seems that six-month naltrexone implants can be an effective and lasting aid to curbing opiate use for the minority of patients motivated to aim for opiate abstinence and prepared to accept that opiate effects may be unavailable to them for six months. Because it does not require the patient to choose to enter aftercare treatment, the option may have a particular role in safeguarding patients emerging opiate-free from prison or other protected environments such as inpatient detoxification centres. However, and despite being motivated to sustain abstinence and being implanted, many if not most patients try opiates again and some do so repeatedly. Details below.

As in the featured study, recruitment in prison seems to have been very slow and no patient volunteered as opposed to being referred by staff. In both studies the minority of potential participants who joined were probably highly motivated to sustain abstinence from opiates because they were prepared to risk random allocation to a procedure which promised to enforce this for up to six months. In the aftercare study they had just completed abstinence-oriented residential care and in the prison study were keen to sustain their enforced abstinence on release.

Across the Norwegian studies implant patients substantially reduced their opiate use during the six months the initial implants were active and in the aftercare study, did so substantially and significantly more than patients allocated to normal aftercare arrangements. However, even among this selected and presumably motivated set of patients, the implants did not totally abolish use of opiate-type drugs and nor did they reduce some other forms of drug use. Just over half the implant patients tested the naltrexone blockade by using opiate-type drugs, and about a quarter of the sample did so repeatedly. Most of this opioid use occurred when naltrexone levels were above those known to block the pleasurable effects of heroin and few patients experienced the usual opiate-induced euphoria or 'high'. Perhaps because nearly a third allocated to implants refused these, in the prison study in particular, the reduction in opiate use was on average modest and no greater than among patients allocated to methadone maintenance.

Of the 61 patients implanted in all the studies, three had the initial implant removed. After six months, 44 said they wanted to be re-implanted and 31 actually were, showing that for some patients the implants can be a long-term treatment rather than simply an enforced break from opiates.

Other studies

In studies a minority of patients experience complications at the insertion site which lead the implant to be removed. Another potential problem is that implants impede opiate-based pain relief. Other occasionally severe reactions to implants and injections have been observed, but generally side effects are mild and/or short-lived and treatable. As with any abstinence-based treatment, overdose due to lost tolerance to opiate-type drugs is a serious concern. However, the few studies to date suggest these products protect against overdose while they are active, and that in caseloads prepared to undertake these procedures, opiate overdose reductions can outlast the active period of the implants. These findings are consistent with findings from Britain (1) and elsewhere (1 2 3 Maksoud N.A. "Experience with detox and naltrexone implants in Egypt." Abstracts from 7th International Conference 2002. Stapleford Trust. 4 5) tentatively suggesting that long-acting naltrexone can be used to create an opiate-free period which extends beyond the initial blockade, sometimes aided by further administrations (1 2). See background notes for more on these important issues of adverse effects and overdose protection.

Another randomised trial of a different long-acting form of naltrexone has been conducted in the USA. Compared to placebo, this injection lasting four weeks nearly doubled the time heroin dependent patients were retained in aftercare following inpatient detoxification. On the credible assumption that drop-outs relapsed, there was a similar impact on heroin use. At the four-week choice point when the naltrexone patients could have refused the second set of injections, few did so, most committing themselves to another period without (or with reduced) opiate effects. Though encouraging, multiple exclusions (such as psychiatric conditions or dependence on other drugs) and the recruitment procedures (partly through newspaper ads) meant the patients may not have been typical of usual caseloads.

A criticism of trials to date is that they included highly selected patients. However, in this they may have reflected normal practice. Patients will only opt for such procedures if they are prepared (irreversibly in the case of depot injections) to commit to weeks or months without the effects of heroin or other opiate-type drugs, or with severely attenuated effects requiring higher than usual doses. From the control groups in naltrexone implant/depot studies, we know that even in these caseloads, treatment drop-out and relapse are common. Long-acting naltrexone helps these highly motivated patients sustain their resolve. The clearest candidates for the treatment are patients who are motivated to return to a life without opiate-type drugs (including prescribed substitutes), have the resources, stability and support to sustain this, are unlikely to simply use other drugs instead, but who when free to experience heroin and allied drugs cannot resist using them, possibly reflected in their poor compliance with oral naltrexone regimens. The treatment may also be considered for unstable patients at very high risk of overdose, but who will not accept or do poorly in substitute prescribing programmes.

Thanks for their comments on this entry in draft to Nikolaj KunKunøe of the Norwegian Centre for Addiction Research, Liv Langberg of the Drammen Council Drug Addiction Prevention Centre in Norway, and Duncan Raistrick of the Leeds Addiction Unit. Commentators bear no responsibility for the text including the interpretations and any remaining errors.

Last revised 28 August 2012. First uploaded

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STUDY 2010 Naltrexone implants compared to methadone: outcomes six months after prison release

STUDY 2015 Opioid treatment at release from jail using extended-release naltrexone: a pilot proof-of-concept randomized effectiveness trial

STUDY 2010 Retention in naltrexone implant treatment for opioid dependence

STUDY 2010 Favorable mortality profile of naltrexone implants for opiate addiction

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STUDY 2011 Outpatient versus inpatient opioid detoxification: a randomized controlled trial

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Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial.

Schottenfeld R.S., Chawarski M.C., Mazlan M.
Lancet: 2008, 371, p. 2192–2200.
Unable to obtain a copy by clicking title? Try asking the author for a reprint by adapting this prepared e-mail or by writing to Dr Schottenfeld at Richard.schottenfeld@yale.edu. You could also try this alternative source.

This unique randomised trial tested what would happen if detoxified opiate addicts were then maintained on a substitute drug, on an opiate-blocking medication, or simply counselled. The results led to the introduction of methadone prescribing programmes in Malaysia.

Summary As a follow-on treatment after opiate detoxification, this study compared the efficacy of the opiate-blocking medication naltrexone, the opiate substitute buprenorphine, or no treatment other than the drug counselling all patients received. In Malaysia at the time naltrexone was the main long-term pharmacotherapy and maintenance substitute prescribing was not permitted.

Between July 2003 and May 2005, 215 people contacted the study of whom 143 heroin dependent patients began a preparatory 14-day detoxification programme Primarily based on buprenorphine and oral naltrexone. in the study's inpatient clinic. Most of the remaining contacts did not complete the study's initial assessments; just 12 were excluded due to complicating conditions. Patients were ineligible if they were dependent on alcohol, benzodiazepines, or sedatives; had concentrations of liver enzymes (alkaline phosphatase or alanine transaminase) greater than three times the upper limit of normal; were a danger to themselves or others; were psychotic or had major depression; or had life-threatening medical problems. In practice all the exclusions related to liver enzyme levels. 126 completed detoxification and started 24 weeks of weekly individual and group drug counselling in the study's outpatient research clinic. For randomly selected patients, counselling was supplemented either by oral naltrexone, sublingual As usual for this medication, the dose was dissolved under the tongue. buprenorphine, or placebos. In the first week the medications were given daily, then multiple doses were given on Mondays, Wednesdays and Fridays. All the doses were consumed under supervision at the clinic and all the patients consumed similar tablets and capsules, either active or placebos depending on their assignment. Nevertheless, most on the active medications correctly identified what they were taking, though most on placebos did not. Typically the patients were poorly educated single men with a history of imprisonment who had been using heroin for on average 15 years and had used near-daily in the previous month.

Outcomes were assessed mainly by urine tests three times a week while patients were still in treatment, the credible 72 of the 84 patients who discontinued treatment early for reasons other than medical disorders had a positive urine test before leaving treatment. assumption being made that the few tests missed by retained patients would have been positive for heroin, and that patients who dropped out of treatment had resumed heroin use. When it became apparent that buprenorphine was clearly the best option, the study was terminated early after 103 patients had completed it and 10 remained in treatment. For these, outcomes were as assessed up to the point the study ended. Retention and time to heroin use or relapse

Supplementing counselling with naltrexone slightly improved treatment retention and heroin use outcomes, but not to a statistically significant degree according to the study's stringent criteria. Because the study had to terminate early, the criterion for a statistically significant difference was doubled from 1 in 20 by chance to 1 in 40. Also (appropriately) two-tailed tests were used which did not assume that one treatment one of the treatments could not be inferior to one of the others. Compared to many studies, together these made a statistically significant finding four times less likely to be registered. In contrast, outcomes on these measures Among other outcomes measured, there were no significant differences on an omnibus measure of infection risk behaviour, but since this relied on patients completing a questionnaire, these results would have been skewed by the higher study drop-out among naltrexone and placebo patients. Substantial risk reductions among patients retained in the study were largely due to reductions in the proportions injecting. were clearly and universally superior for the buprenorphine patients, significantly better than placebo, and generally also significantly better than naltrexone. For example, of the 24 weeks patients could have stayed in treatment, on buprenorphine they stayed on average for 17 weeks, naltrexone 12, and placebo 10 chart. Corresponding figures for retention without a positive/missed test for heroin use were 7, just over 3, and just under 3 weeks. For retention without relapse Defined as three consecutive opiate-positive urine tests, or an opiate-positive test followed by two consecutive positive or missing tests. to sustained heroin use, the figures were 11, 9, and just under 6 weeks.

For the authors their findings showed the efficacy of maintenance treatment with buprenorphine in sustaining abstinence, delaying time to resumption of heroin use and relapse, and retaining patients in treatment, lending support to the widespread dissemination of maintenance treatment with buprenorphine as an effective public health approach to heroin dependence.

Findings logo commentary Uniquely the study answered the question: What would happen if continuing care for patients who completed detoxification consisted of low intensity counselling only or with attempts to sustain abstinence using naltrexone, versus effectively accepting that many will relapse and instead prescribing a substitute drug? When these were the only options available, the answer seemed to be that naltrexone offers no substantial advantages, but that substitute prescribing As the authors comment, since methadone is if anything (see http://findings.org.uk/PHP/dl.php?file=bup_meth.nug) superior to buprenorphine in terms of retention in treatment, the findings can be extended also to this medication when prescribed daily. Presumably in recognition of this, the study led to methadone prescribing being approved in Malaysia. makes a big difference to how long and how many patients are able to live without regular resort to illegal opiates. Without this, for most rapid relapse is the norm even after they have been able to complete detoxification; opiate blocking medication does little to improve the situation.

Though this is the verdict from among the range of options on offer in the study, long-acting forms of naltrexone which last weeks or months might have tipped the balance in favour of abstinence-based therapy, and seamless entry in to (to the patient) acceptable forms of residential rehabilitation or intensive day care might have raised outcomes to the point where the choice of medication was less decisive. In both cases, the caveat is that compared to substitute prescribing, fewer patients are prepared to accept or can access these options, and in the case of residential rehabilitation, the costs per year of heroin use averted are likely to be considerably greater.

The main issue with the study from a UK perspective is its applicability to a country where these are not the only options available, and where even if they were, patients would be expected to be allocated to them on an individual basis in the light of what seems best for that individual. However, there are parallels. As in the featured study, in the UK (and elsewhere) failure to complete detoxification or post-detoxification relapse are the norm, long-acting naltrexone formulations have yet to be licensed and made widely available, and residential rehabilitation remains in short supply. The relevance of the study could be heightened if (as strongly advocated by some political advisers) substitute prescribing is de-emphasised in favour of abstinence-based approaches, especially if the need for economies forces these to take the form of naltrexone or counselling rather than intensive, extensive and expensive psychosocial rehabilitation.

Currently the study usefully reinforces existing guidance on the need for anti-relapse support after detoxification, the limitations "Naltrexone is recommended as a treatment option in detoxified formerly opioid-dependent people who are highly motivated to remain in an abstinence programme." of oral naltrexone as a means of providing or reinforcing that support, and the more widespread applicability and more securely established effectiveness of substitute prescribing using methadone or buprenorphine. It also provides an argument for maintenance prescribing to be made rapidly available for the many patients unable to avoid a return to regular opiate use after detoxification.

The implications of the study are supported by other studies of detoxification, oral naltrexone and substitute prescribing, though no other study has within itself compared these options. As commentators on the study put it, this wider research base indicates that "The preferred oral pharmacological treatment for opioid dependence should be agonist maintenance with either methadone or buprenorphine." This verdict carefully limited itself to "pharmacological" treatments and to "oral" Or in the case of buprenorphine, sublingual. medications, leaving out more intensive or improved psychosocial approaches or long-acting implanted or injected medications.

In Australia, where polarised opinions favoured substitute prescribing or rejected this in favour of naltrexone, the federal parliament reacted by conducting a review of their respective advantages in the Australian context. The conclusion was that both had their place, but that place was much greater for substitute prescribing. Oral naltrexone was seen as a niche option for the minority of opioid-dependent individuals capable of remaining compliant with the treatment, but for most it had been consistently been linked with high rates of non-compliance, a greater risk of death and reduced likelihood of long-term success. In contrast, methadone and other opioid substitution treatments were seen as widely applicable treatments acknowledged as effective in reducing opioid dependence and associated health and social problems.

The featured study seems to support this conclusion, but perhaps not as strongly as it might have done. On one key measure – retention without relapse to sustained heroin use – buprenorphine's advantage over naltrexone was small (two weeks) and not statistically significant, possible an artefact of the way relapse was defined. The definition meant that patients whose last test was negative for heroin, and who then dropped out of treatment, would not have been counted as relapsed. This seems more likely to have happened among the naltrexone patients, who while still in treatment would have found heroin's effects blocked by the medication. Despite its advantages, at best 18 of 44 were in treatment for the full 24 weeks but four more remained in treatment when the study terminated. half the patients on buprenorphine stayed in treatment for six months, less than in other studies possibly due to insufficiently supportive psychosocial care, or because the study's standard dose 8mg daily which could be increased if needed. was at the lower end of what is considered effective. It also seems likely that buprenorphine's advantage would have been greater had patients not been required to complete detoxification in advance, presumably weeding out those less able or willing to attain abstinence from opiates. On the other hand, the naltrexone patients might have been disadvantaged by the dosing schedule. Both buprenorphine and naltrexone are known to be able to bridge alternate-day dosing schedules, but in studies naltrexone is normally taken daily, providing a daily reminder to the patient that any heroin they try will be more or less wasted. Dosing every two or three days left gaps during which the patients might have been tempted to try heroin. However, this schedule probably reflects how both drugs are commonly prescribed in normal practice.

Thanks for their comments on this entry in draft to Brian Kidd of Tayside Drug Problems Service and University of Dundee Medical School, and John Witton of the National Addiction Centre in London. Commentators bear no responsibility for the text including the interpretations and any remaining errors.

Last revised 17 July 2009

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Top 10 most closely related documents on this site. For more try a subject or free text search

STUDY 2011 Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial

STUDY 2010 Favorable mortality profile of naltrexone implants for opiate addiction

REVIEW 2011 Oral naltrexone maintenance treatment for opioid dependence

STUDY 2010 Unobserved versus observed office buprenorphine/naloxone induction: a pilot randomized clinical trial

STUDY 2010 Ultra-rapid opiate detoxification followed by nine months of naltrexone maintenance therapy in Iran

STUDY 2011 Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence

DOCUMENT 2013 Community loses from failure to offer maintenance prescribing in prisons

REVIEW 2012 The effectiveness of opioid maintenance treatment in prison settings: a systematic review

STUDY 2009 Naltrexone implants after in-patient treatment for opioid dependence: randomised controlled trial

DOCUMENT 2009 Guidelines for the psychosocially assisted pharmacological treatment of opioid dependence

Distributing foil from needle and syringe programmes (NSPs) to promote transitions from heroin injecting to chasing: an evaluation.

Pizzey R., Hunt N.
Harm Reduction Journal: 2008, 5:24.
Unable to obtain a copy by clicking title? Try asking the author for a reprint by adapting this prepared e-mail or by writing to Dr Hunt at Neil.Hunt@lshtm.ac.uk.

British needle exchanges which piloted distribution of foil packs for smoking heroin found they were widely used and may have increased attendance and reduced the number of injections, lending weight to calls to legalise such provision.

Summary Though by no means safe, smoking heroin is considerably safer than injecting because it reduces the chances of viral transmission and overdose and eliminates injecting site damage. Commonly foil is used as a container for the heroin while it is heated and the fumes inhaled, known as 'chasing' illustration. The featured study aimed to test whether making high quality, customised foil sheets freely available from needle exchanges (in the form of packs with written material encouraging transition from injecting to smoking and other information) would be acceptable to opiate users visiting the exchanges and what effect this would have on exchange usage and heroin consumption methods.

'Chasing' heroin

The packs were developed by Exchange Supplies and piloted at four needle exchange programmes in south west England in 2006 and 2007. Just over half (54%) of the 320 opiate users who visited the exchanges during this period took up the offer of the packs, a proportion which was fairly consistent across the exchanges. Since sometimes they were not offered to visitors, the acceptance rate was actually higher by an unknown amount. Staff tended to prioritise visitors running the greatest injecting-related risks, and found that being able to offer foil provided an opportunity to discuss these risks and the benefits of transition to non-injecting routes of administration. While foil was available, visits to the exchanges increased by a third from 1672 to 2216. To obtain foil, 32 new visitors attended the services who chased heroin but did not inject, drug users who would presumably otherwise not have made contact.

At one of the exchanges 48 injectors who had taken foil were interviewed the first time they did so and again when they next returned to the service, normally within four weeks of the initial visit. All had previously smoked heroin and were familiar with using foil to do so. At the second visit, all but two said they had used the foil and 41 (85%) said that as a result they had smoked when they would otherwise have injected. They universally agreed that foil provision was useful. Several reported that because the foil was provided free, it was available when otherwise it would not have been due to lack of money, the inconvenience of buying it, or because buying it might embarrassingly expose them as heroin users. Some deliberately turned to smoking when they particularly wanted to avoid injecting. Several took foil home for their smoking partners. Among the people who took them, satisfaction with the quality and size of the foil packs was good.

The authors concluded that distributing foil packs can be a useful means of engaging exchange attenders in discussions about ways of reducing injecting risks and can reduce injecting in settings where there is a pre-existing culture of smoking heroin by this method. There is also the potential for wider changes among local networks of injectors in contact with exchange visitors.

Findings logo commentary As the authors acknowledged, this small study is best considered a test of the feasibility and acceptability of the packs and an indication of their possible impact, which may or may not be replicated in more usual circumstances and at other exchanges. Among the reasons for caution are that it was conducted by enthusiastic practitioners, who themselves sought feedback from service users, obtained it in structured form from only a small and possibly unrepresentative minority, and that the study lacked a comparison set of exchanges not offering foil packs. The authors are also careful to limit their conclusions to areas where smoking heroin is already well established, though in Britain this is not too much of a limitation.

Another report Boid. A., Waldock. D. "The introduction of aluminium foil to Sidney Street Needle Exchange and Sharp Action mobile needle exchange Sheffield." Turning Point, 2008. provided feedback on a trial scheme providing foil from a site-based and a mobile exchange, which indicated that this reduced injecting behaviour and promoted less risky alternatives. An account of its findings says the initiative had many harm reduction benefits. Providing foil enabled workers to engage with injectors about the possibility of smoking. Foil was taken by 85 service users, of whom 72% had injected in the last four weeks, 81% had previously smoked heroin and 12% had not used the service before. A third provided feedback, of which 32 had used the foil, 21 used it daily but eight had either not or rarely used; 27 said their injecting had reduced. Case studies of eight individuals revealed that new clients were seen due to the initiative; most had reduced their injecting and some had replaced injecting entirely with smoking.

If the intervention does prove itself more widely, the benefits could be considerable. Intercepting the transmission of hepatitis C requires greater risk reduction than exchanges can normally achieve; moving away from injecting altogether would be a much bigger step which would substantially reduce transmission. Most people surveyed for the featured study did not go this far, continuing to inject but smoking more often, possibly leaving enough residual unsafe injecting to transmit the virus. A common pattern was to use the foil and smoke when users specially wanted to avoid injecting. If among these occasions they included (or could be persuaded to include) times when injecting meant sharing equipment, risk reduction would be greater and more likely to seriously dent spread of hepatitis C. Overdose deaths are another major concern, particularly in Scotland, but needle exchange on its own can do little to reduce the toll. Here too a move away from injecting would almost certainly make a substantial contribution. In relation to both these major risks, foil provision offers exchanges a potentially important tool.

These were among the reasons which led the Advisory Council on the Misuse of Drugs – an expert body set up under the Misuse of Drugs Act to advise government – to recommend foil be exempted from Misuse of Drugs Act provisions which ban supply of equipment which can be used to prepare or take illegal drugs, in the same way that needles and syringes and other items used in injecting are exempt to enable needle exchanges to operate within the law. Without such a change, needle exchanges can supply equipment to make the most dangerous method of drug use (injecting) somewhat less risky, but are unable legally (though this does happen and is not prosecuted) to supply equipment which might support transition to a far less dangerous method (smoking). This legal barrier may have led the UK's National Institute for Health and Clinical Excellence (NICE) to recommend that needle exchanges "encourage [their users] to ... switch to non-injecting methods", but not to advocate the distribution of equipment to facilitate this transition. Consulted on the guidance, people working with needle exchange programmes were disappointed with this omission. Their comments were in line with the results of a survey conducted in 2008 of UK needle exchange workers. Due mainly to the law, just 15% of the 445 respondents said their services distributed foil, but most supported its provision as a useful harm reduction intervention for both heroin and crack cocaine users.

In the late 2000s attempts were made to remove or amend legal restrictions on supplying foil and other items by medical and drug services when acting in their professional capacity. These were accepted in principle by the government of the time but fell victim to the impending May 2010 election. Apart from illegality, another objection to foil provision may be cost, but in so far as it does reduce the number of injections, it will presumably also reduce the demand for injecting equipment from exchanges, saving money on that front.

Thanks for their comments on this entry in draft to Neil Hunt of the University of Kent and the London School of Hygiene and Tropical Medicine, Andrew Preston of Exchange Supplies, and John Witton of the National Addiction Centre. Commentators bear no responsibility for the text including the interpretations and any remaining errors.

Last revised 22 January 2013. First uploaded 04 July 2009

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Substance use outcomes 5½ years past baseline for partnership-based, family-school preventive interventions.

Spoth R.L., Randall G.K., Trudeau L. et al.
Drug and Alcohol Dependence: 2008, 96(1–2), p, 57–68.
Unable to obtain a copy by clicking title? Try asking the author for a reprint by adapting this prepared e-mail or by writing to Dr Spoth at rlspoth@iastate.edu.

Two of the most widely recommended US school and family prevention programmes retarded growth in some forms of substance use, especially among youngsters who had already used by their early teens, but there are some methodological concerns over the findings.

Summary 36 secondary schools in the rural US mid-west were randomly allocated to either carry on as normal (the control A group of people, households, organisations, communities or other units who do not participate in the intervention(s) being evaluated. Instead, they receive no intervention or none relevant to the outcomes being assessed, carry on as usual, or receive an alternative intervention (for the latter the term comparison group may be preferable). Outcome measures taken from the controls form the benchmark against which changes in the intervention group(s) are compared to determine whether the intervention had an impact and whether this is statistically significant. Comparability between control and intervention groups is essential. Normally this is best achieved by randomly allocating research participants to the different groups. Alternatives include sequentially selecting participants for one then the other group(s), or deliberately selecting similar set of participants for each group. schools) or to one of two prevention programmes. Both were delivered primarily in the seventh grade (ages 12–13), and both featured the LifeSkills Training (LST) drug education curriculum consisting of fifteen classroom lessons with later 'boosters'. In one set of schools, these lessons were supplemented by the Strengthening Families Program: for Parents and Youth 10-14. This entails seven two-hour evening sessions plus four booster sessions in the following year, during which groups of about six or seven families focus in turn on particular parenting issues and skills. In the first hour of each session, parents and children learn in parallel; in the second, they come together to practice these skills with each other. Only a quarter of the families allocated to these (and 38% of those actively recruited) attended any of the family sessions, but results are reported for all the families offered the intervention, regardless of attendance.

Questionnaire responses from 1677 pupils surveyed about six months before the grade seven lessons formed the baseline to assess changes in substance use among the same pupils over each of the five years following the lessons. Typically by then aged 17–18, about three quarters of the starting sample responded to the final assessments. For the featured report the sample was narrowed down slightly to pupils who had provided the relevant outcome measures at least three times: at baseline; about a month after the seventh grade interventions; and during at least one follow-up. For these pupils, the analysis tested whether over the five and a half years:
• trends in the growth of substance use differed between the three sets of schools; and
• whether by the end levels of substance use also differed.

First the study assessed how many pupils had started to use alcohol, cigarettes or cannabis. Most consistently positive results were found for cigarettes; growth in the proportion who had tried smoking, and the final proportion who had used by age 17–18, were significantly lower in intervention schools compared to control schools. For cannabis, only the final proportion was significantly lower, and for alcohol, only the growth trend, and then only when the family intervention had supplemented the lessons. When these measures were combined in an index representing experience of all three substances, both the growth trend and the final outcomes favoured the interventions. Experience of getting drunk was also measured and, like drinking itself, only the growth trend favoured the interventions.

Similar analyses for current use on at least a monthly basis and other more serious patterns of substance use found no results favouring the interventions. However, there were such results among the fifth of pupils considered at high risk of developing substance use problems. These were the pupils who at the first survey point at age 12–13 had already used two of the three substances. Compared to their lower risk peers, among these pupils both interventions had consistently An exception was the frequency with which the pupils got drunk. There were also some significant growth trend differences, notably for the frequency of cannabis use and an index of monthly use of all three substances. greater effects on overall levels of use across the follow-up years. Further analysis showed that among lower risk pupils, the interventions made no significant difference. But among the higher risk fifth,growth in the average frequency of smoking cigarettes or using cannabis was less than in the control schools, and so too was final average frequency of use. This was not the case for the frequency of drinking or of getting drunk; for these measures only two Final frequency of use and of drunkenness after the LifeSkills curriculum without the family intervention supplement. of the eight outcomes significantly favoured the interventions. Among the same higher risk pupils, indices of serious use patterns combining measures of current or past use of all three substances Plus solvent misuse for one of the indices. consistently favoured the intervention schools.

Summarising their findings, the authors noted that for all substance initiation outcomes, one or both intervention groups showed significant, positive differences compared with the control group in the final follow-up year, and/or significant differences in growth trends over the five years since the interventions. In contrast, across all the pupils, more serious substance use outcomes reflecting mainly current and frequent use were not significantly affected. However, these forms of substance use were curbed when the analysis was restricted to higher risk pupils. Though the two interventions often bettered education-as-usual, in no case did one outperform the other. The authors speculated that less convincing initiation-prevention results than in earlier studies might have been due to the family intervention being delayed a year, when more pupils had already initiated substance use. In terms of affecting more serious forms of substance use, pupils already advanced in their substance use patterns responded relatively well, possibly because the messages were more 'real' for them and for their parents. Despite randomisation, there remained some significant baseline differences between control and intervention pupils which might also have obscured intervention impacts, though attempts were made to adjust for these in the analyses.

Findings logo commentary The two programmes tested in the study enjoy among the most widely respected research records in substance use prevention (LST SFP). The featured study's strengths include large samples, reasonable follow-up rates, randomisation by school and an analysis controlling for the influence of the school itself, and outcome measures probing not just experience of the substances concerned, but how serious and lasting this was. Nevertheless the most which can be said is that the LifeSkills Training element probably retarded the initiation of smoking, possibly cannabis use, but not drinking, had no cross-sample benefits in respect of the forms of substance use of greatest concern, but may have had such benefits among the minority of pupils already relatively advanced in their substance use before the interventions started. Other LifeSkills Training studies have also most consistently found beneficial outcomes in respect of smoking, the programme's original target.

Focusing on the featured study's positive findings might give the impression of more all round success, but in respect of the full samples, these consisted of at most 13 out of 44 findings, and possibly (if arguably more appropriate methodological conventions had been followed) seven or fewer. Greater and more consistent success among the higher risk pupils is a tentative finding because of differences between intervention and control schools, because the study was not set up to test this subsample, and because of some methodological issues. Impacts on the forms of drug use of greatest concern emerged solely from this analysis, meaning that the interventions' ability to reduce these cannot be considered to have been demonstrated, though the possibility that this might prove to be the case is encouraging. Importantly, though many tests did not show the interventions were superior to education-as-usual, none Personal communication from Dr Spoth, July 2009. indicated that they were inferior; the only significant findings favoured the interventions. For more on all these issues see background notes.

Disappointingly, and despite earlier findings from the study, there was no real hint that adding the family programme improved on the school lessons in terms of the substance use measures reported in the study, though there may have been other benefits. Remaining support for the family programme comes mainly from a study whose findings (impressive as they were) derived from just over a third Though every family who participated and supplied the relevant data was included in the analysis regardless of whether they had attended the sessions. Also on all but one (parent education) of the variables measured (parent education, household income, target child gender, parent marital status, number of children, child conduct problems, and social-emotional distress), the families who participated in the study did not differ from those who did not. of the mainly white and rural families asked to participate in the study. A similar limitation applies to a later study of a substantially revised version among poor black families. Because of the way they were designed, these trials could establish benefits only among the minority of families prepared or able to participate in the interventions and complete the studies; they cannot be considered a secure indication of how the interventions would perform if applied across the board. So far in the UK a small pilot study has established the programme's feasibility among a small set of families.

This leaves two of the most thoroughly researched universal prevention programmes for children of secondary school age with mixed findings of uncertain relevance to how they might perform if truly applied across the board. At least part of the problem lies in not in whether the benefits of these programmes are (or at least, can be) real, but in the difficulty of showing they are real. Verdicts in respect of drinking that public health strategies built on education and persuasion are relatively ineffective compared to measures such as restricting availability and raising price, would not be altered by the featured study. For smoking, the case for education in schools as a public health strategy is considerably stronger. Universal prevention programmes in general, and school-based programmes in particular, have greater impacts on tobacco use than on use of the other two substances featured in the study.

Some evidence supports the modest effectiveness of school programmes in preventing cannabis use. But of the four studies on which this verdict was based, one was a primary school programme not focused on substance use at all but on classroom management, education and parenting, another was conducted only among pupils for some reason excluded from mainstream education, and the programme studied in a third has since failed in a more real-world study conducted by researchers not associated with its development. The remaining study was conducted in secondary schools and concerned LifeSkills Training, but the impact on cannabis use was not statistically significant. This line up does not offer much support to drug education in mainstream secondary schools as a means of preventing cannabis use.

Mixed findings of a prevention impact from school programmes targeting substance use do not negate the possibility that general attempts to create schools conducive to healthy development will affect substance use along with other behaviours, nor do they relieve schools of the obligation to educate their pupils on this important aspect of our society. As much as the limited research, such considerations led the UK's National Institute for Health and Clinical Excellence (NICE) to recommend that alcohol education should be an integral part of national science and health education curricula, in line with government guidance.

Thanks for their comments on this entry in draft to Richard Spoth of Iowa State University, Andrew Brown of the Drug Education Forum and David Foxcroft of Oxford Brookes University. Commentators bear no responsibility for the text including the interpretations and any remaining errors.

Last revised 02 July 2009. First uploaded

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