A study protocol for a European, mixed methods, prospective, cohort study of the effectiveness of naloxone administration by community members, in reversing opioid overdose: NalPORS.

BACKGROUND: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide 'community members', who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions. METHODS: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design. DISCUSSION: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021.

The Cost-Effectiveness of Financial Incentives to Achieve Heroin Abstinence in Individuals With Heroin Use Disorder Starting New Treatment Episodes: A Cluster Randomized Trial-Based Economic Evaluation.

OBJECTIVES: Cost-effectiveness analysis of two 12-week contingency management (CM) schedules targeting heroin abstinence or attendance at weekly keyworker appointments for opioid agonist treatment compared with treatment as usual (TAU). METHODS: A cost-effectiveness analysis was conducted alongside a cluster randomized trial of 552 patients from 34 clusters (drug treatment clinics) randomly allocated 1:1:1 to opioid agonist treatment plus weekly keyworker appointments with (1) CM targeted at heroin abstinence (CM abstinence), (2) CM targeted at on-time attendance at weekly appointments (CM attendance), or (3) no CM (TAU). The primary cost-effectiveness analysis at 24 weeks after randomization took a societal cost perspective with effects measured in heroin-negative urine samples. RESULTS: At 24 weeks, mean differences in weekly heroin-negative urine results compared with TAU were 0.252 (95% confidence interval [CI] -0.397 to 0.901) for CM abstinence and 0.089 (95% CI -0.223 to 0.402) for CM attendance. Mean differences in costs were £2562 (95% CI £32-£5092) for CM abstinence and £317 (95% CI -£882 to £1518) for CM attendance. Incremental cost-effectiveness ratios were £10 167 per additional heroin-free urine for CM abstinence and £3562 for CM attendance with low probabilities of cost-effectiveness of 3.5% and 36%, respectively. Results were sensitive to timing of follow-up for CM attendance, which dominated TAU (better outcomes, lower costs) at 12 weeks, with an 88.4% probability of being cost-effective. Probability of cost-effectiveness remained low for CM abstinence (8.6%). CONCLUSIONS: Financial incentives targeted toward heroin abstinence and treatment attendance were not cost-effective over the 24-week follow-up. Nevertheless, CM attendance was cost-effective over the treatment period (12 weeks), when participants were receiving keyworker appointments and incentives.

A qualitative exploration of patients' experience of mobile telephone-delivered contingency management to promote adherence to supervised methadone.

INTRODUCTION: Despite an increasing evidence base for mobile telephone-delivered contingency management (mCM), there had been no previous qualitative exploration of patients' experience of receiving mCM and the factors that might influence that experience and outcome in a UK setting. The aim of this study was to understand patients' views and experience of receiving mCM by exploring their beliefs, expectations and perceived benefits within the context of the UK's first mCM intervention. METHODS: Qualitative interviews (N = 15) were conducted with patients undergoing opioid agonist treatment in a UK drug treatment service and receiving mCM to encourage adherence with supervised methadone as part of an existing study. Interviews were conducted at two time points and analysed using Framework to explore patients' expectations and beliefs during the early stage of the intervention (2 weeks) and their perceived benefits and experience at the end of the intervention (12 weeks). RESULTS: The mCM was perceived as a motivator, providing validation of achievement, and involving discreet and positive interactions. Perceived benefits included enhanced methadone adherence, reduced drug use and the development of a supportive and non-judgemental connection that resembled a therapeutic alliance. DISCUSSION AND CONCLUSIONS: The mechanisms underpinning contingency management appeared to operate in the absence of human interaction, and the mCM intervention was deemed to be meaningful, acceptable and well received by patients. These findings not only provide support for the application of mCM in this context but also offer insight into the factors that influence outcomes and should be considered in the development of future mCM interventions.

Substance use and homelessness: A longitudinal interview study conducted during COVID-19 with implications for policy and practice.

BACKGROUND: People who are homeless and using substances frequently encounter barriers to accessing support. This paper aims to inform policy and practice by analysing changes in the tobacco, alcohol and illicit drug use of people experiencing homelessness. METHODS: Data derive from a qualitative longitudinal study (undertaken 2020/2021) and involving telephone interviews (n = 310) conducted with 34 people accommodated in two London hotels provided as part of a UK policy response to COVID-19. The hotels offered various supports, including opioid replacement therapy, prescribed alcohol, licensed nicotine replacement therapy, and e-cigarettes. Participants' substance use data were organised by Iterative Categorization and subjected to a content analysis to identify patterns and themes.. RESULTS: At entry to the hotel, 5/34 participants (14.7%) had never used alcohol nor illicit drugs; 10/34 (29.4%) had only ever used alcohol (mostly without a problem); 11/34 (32.4%) had ever used illicit drugs but without a problem; and 8/34 (23.5%) had ever had a problem with illicit drugs. Sub-groups had different socio-demographic characteristics, particularly regarding being/not being a UK national, sex, and homelessness duration. Tobacco smoking was common across all sub-groups (18/34; 52.9%). Participants were often anxious about living with others who were using substances, and some worried about their own substance use. Substance use was changeable, with more decreases than increases. Changes related to intrapersonal (psychological), interpersonal (social) and structural (resource-based) factors. For example, decreases were precipitated by people feeling motivated to change, separation from others who used drugs, and receiving treatment or support. CONCLUSION: Findings indicate that various interventions and accommodation models may benefit people who are homeless and using substances. An initiative that combined shelter and basic amenities, pharmacological treatment, psychosocial support, and space where substances were not available and other people using substances could be avoided resulted in an overall reduction in substance use amongst those accommodated.

A rapid assessment of take-home naloxone provision during COVID-19 in Europe.

BACKGROUND: In March 2020, the World Health Organization declared COVID-19 a global pandemic. In the following weeks, most European countries implemented national lockdowns to mitigate viral spread. Services for people who use drugs had to quickly revise their operating procedures to rearrange service provision while adhering to lockdown requirements. Given the scarcity of literature published on overdose prevention during COVID-19 in Europe, we aimed to examine how these changes to service provision affected take-home naloxone (THN) programmes and naloxone availability across Europe. METHODS: Between November 2020 and January 2021, we conducted a rapid assessment with country experts from European countries that provide THN. We sent country experts a template to report monthly THN distribution data (January 1, 2019-October 31, 2020) and a structured 6-item survey for completion. RESULTS: Responses were received from 14 of the 15 European countries with THN provision of which 11 participated in the rapid assessment: Austria, Denmark, England, Estonia, Lithuania, Northern Ireland, Norway, Scotland, Spain (Catalonia only), Sweden, and Wales. All reported reduced organisational capacity during COVID-19, and some put into place a range of novel approaches to manage the restrictions on face-to-face service provision. In six countries, the introduction of programme innovation occurred alongside the publication of government guidelines recommending increased THN provision during COVID-19. Eight of the eleven participating countries managed to maintain 2019-level monthly THN distribution rates or even increase provision during the pandemic. CONCLUSION: Through programme innovation supported by public guidelines, many European THN programmes managed to ensure stable or even increased THN provision during the pandemic, despite social distancing and stay-at-home orders affecting client mobility.

Patients' beliefs towards contingency management: Target behaviours, incentives and the remote application of these interventions.

INTRODUCTION: Contingency management interventions are among the most efficacious psychosocial interventions in promoting abstinence from smoking, alcohol and substance use. The aim of this study was to assess the beliefs and objections towards contingency management among patients in UK-based drug and alcohol services to help understand barriers to uptake and support the development and implementation of these interventions. METHODS: The Service User Survey of Incentives was developed and implemented among patients (N = 181) at three UK-based drug and alcohol treatment services. Descriptive analyses were conducted to ascertain positive and negative beliefs about contingency management, acceptability of different target behaviours, incentives and delivery mechanisms including delivering incentives remotely using technology devices such as mobile telephones. RESULTS: Overall, 81% of participants were in favour of incentive programs, with more than 70% of respondents agreeing with the majority of positive belief statements. With the exception of two survey items, less than a third of participants agreed with negative belief statements. The proportion of participants indicating a neutral response was higher for negative statements (27%) indicating greater levels of ambiguity towards objections and concerns regarding contingency management. DISCUSSION AND CONCLUSIONS: Positive beliefs towards contingency management interventions were found, including high levels of acceptability towards a range of target behaviours, incentives and the use of technology devices to remotely monitor behaviour and deliver incentives. These findings have implications for the development and implementation of remote contingency management interventions within the UK drug treatment services.

Using a pragmatically adapted, low-cost contingency management intervention to promote heroin abstinence in individuals undergoing treatment for heroin use disorder in UK drug services (PRAISE): a cluster randomised trial.

INTRODUCTION: Most individuals treated for heroin use disorder receive opioid agonist treatment (OAT)(methadone or buprenorphine). However, OAT is associated with high attrition and persistent, occasional heroin use. There is some evidence for the effectiveness of contingency management (CM), a behavioural intervention involving modest financial incentives, in encouraging drug abstinence when applied adjunctively with OAT. UK drug services have a minimal track record of applying CM and limited resources to implement it. We assessed a CM intervention pragmatically adapted for ease of implementation in UK drug services to promote heroin abstinence among individuals receiving OAT. DESIGN: Cluster randomised controlled trial. SETTING AND PARTICIPANTS: 552 adults with heroin use disorder (target 660) enrolled from 34 clusters (drug treatment clinics) in England between November 2012 and October 2015. INTERVENTIONS: Clusters were randomly allocated 1:1:1 to OAT plus 12× weekly appointments with: (1) CM targeted at opiate abstinence at appointments (CM Abstinence); (2) CM targeted at on-time attendance at appointments (CM Attendance); or (3) no CM (treatment as usual; TAU). Modifications included monitoring behaviour weekly and fixed incentives schedule. MEASUREMENTS: Primary outcome: heroin abstinence measured by heroin-free urines (weeks 9-12). SECONDARY OUTCOMES: heroin abstinence 12 weeks after discontinuation of CM (weeks 21-24); attendance; self-reported drug use, physical and mental health. RESULTS: CM Attendance was superior to TAU in encouraging heroin abstinence. Odds of a heroin-negative urine in weeks 9-12 was statistically significantly greater in CM Attendance compared with TAU (OR=2.1; 95% CI 1.1 to 3.9; p=0.030). CM Abstinence was not superior to TAU (OR=1.6; 95% CI 0.9 to 3.0; p=0.146) or CM Attendance (OR=1.3; 95% CI 0.7 to 2.4; p=0.438) (not statistically significant differences). Reductions in heroin use were not sustained at 21-24 weeks. No differences between groups in self-reported heroin use. CONCLUSIONS: A pragmatically adapted CM intervention for routine use in UK drug services was moderately effective in encouraging heroin abstinence compared with no CM only when targeted at attendance. CM targeted at abstinence was not effective. TRIAL REGISTRATION NUMBER: ISRCTN 01591254.

Rethinking 'carriage' of take-home naloxone.

Take-home naloxone (THN) provision to people who use drugs, their family/friends, and non-medical personnel is considered a public health strategy to improve community-based naloxone access and reduce the time to antidote treatment for opioid overdose in order to prevent fatal outcome. THN programs typically report up to three performance indicators: the volume of THN kits distributed, the rate of requests for re-supply of THN kits (e.g., following naloxone use for overdose reversal), and - increasingly - THN "carriage". In this Research Methods piece, we discuss the current shortcomings in the latter measurement of THN carriage from a mixed-methods perspective and describe possible implications for public health related research and improved data analyses. We present an argument for the need to improve research methods in the case of THN "carriage" and propose a multidimensional measurement structure that takes into account: 1) the location of the THN kit relative to its owner, 2) the owner's immediate access to the kit in an emergency, 3) the type of THN device, and 4) the purpose of THN ownership (i.e., for use in self or known/unknown other/s).

Telephone delivered incentives for encouraging adherence to supervised methadone consumption (TIES): Study protocol for a feasibility study for an RCT of clinical and cost effectiveness.

The majority of people receiving treatment for their heroin addiction, are prescribed methadone; for which there is an extensive evidence base. When treatment starts, people take their daily dose of methadone under supervision at a community pharmacy. Supervision guarantees methadone is taken as directed by the individual for whom it has been prescribed, helps to ensure individuals take their correct dose every day, and safeguards against diversion and overdose. However, individuals often fail to attend the pharmacy to take their methadone. Each missed dose is of concern. If a patient misses their daily dose of methadone, they will start to experience opiate withdrawal and cravings and are more likely to use heroin. If they miss three days dose, there are concerns that they may lose tolerance to the drug and may be at risk of overdose when the next dose is taken. Hence there is an urgent need to develop effective interventions for medication adherence. Research suggests that incentive-based medication adherence interventions may be very effective, but there are few controlled trials and the provision of incentives requires time and organisational systems which can be challenging in pharmacies. The investigators have developed the technology to deliver incentives by mobile telephone. This cluster randomised trial will test the feasibility of conducting a future trial evaluating the clinical and cost effectiveness of using telephone delivered incentives (praise and modest financial rewards via text messaging) to encourage adherence with supervised consumption of methadone in community pharmacies. Three drug services (each with two or three community pharmacies supervising methadone consumption that will enrol 20 individuals, a total of 60 participants) will be recruited and randomly allocated to deliver either i) telephone delivered incentives, ii) telephone delivered reminders or iii) no telephone system. Acceptability, recruitment, follow-up, and suitable measures of clinical and cost effectiveness will be assessed. Findings from this feasibility study will be assessed against stated progression criteria and used to inform a future confirmatory trial of the clinical and cost effectiveness of telephone delivered incentives to encourage medication adherence. TRIAL REGISTRATION: ISRCTN58958179 (retrospectively registered).

Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis.

BACKGROUND/AIMS: Contingency management (CM) interventions have gained considerable interest due to their success in the treatment of addiction. However, their implementation can be resource-intensive for clinical staff. Mobile telephone-based systems might offer a low-cost alternative. This approach could facilitate remote monitoring of behaviour and delivery of the reinforcer and minimize issues of staffing and resources. This systematic review and meta-analysis assessed the evidence for the effectiveness of mobile telephone-delivered CM interventions to promote abstinence (from drugs, alcohol and tobacco), medication adherence and treatment engagement among individuals with substance use disorders. DESIGN: A systematic search of databases (PsychINFO, CINAHL, MEDLINE PubMed, CENTRAL, Embase) for randomized controlled trials and within-subject design studies (1995-2019). The review was conducted in accordance with the PRISMA statement. The protocol was registered on PROSPERO. SETTING: All included studies originated in the United states. PARTICIPANTS: Seven studies were found, including 222 participants; two targeted alcohol abstinence among frequent drinkers and four targeted smoking cessation (in homeless veterans and those with post-traumatic stress disorder). One targeted medication adherence. MEASURES: The efficacy of CM to increase alcohol and nicotine abstinence was compared with control using several outcomes; percentage of negative samples (PNS), quit rate (QR) and longest duration abstinent (LDA) at the end of the intervention. FINDINGS: The random-effects meta-analyses produced pooled effect sizes of; PNS [d = 0.94, 95% confidence interval (CI) = 0.63-1.25], LDA (d = 1.08, 95% CI = 0.69-1.46) and QR (d = 0.46, 95% CI = 0.27-0.66), demonstrating better outcomes across the CM conditions. Most of the studies were rated as of moderate quality. 'Fail-safe N' computations for PNS indicated that 50 studies would be needed to produce a non-significant overall effect size. None could be calculated for QR and LDA due to insufficient number of studies. CONCLUSION: Mobile telephone-delivered contingency management performs significantly better than control conditions in reducing tobacco and alcohol use among adults not in treatment for substance use disorders.

An economic evaluation of contingency management for completion of hepatitis B vaccination in those on treatment for opiate dependence.

AIMS: To determine whether the provision of contingency management using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of health-care resources. DESIGN: A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. SETTINGS AND PARTICIPANTS: Data on attendance to vaccination from a UK cluster randomized trial. INTERVENTION: Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. MEASUREMENT: Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. FINDINGS: The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programme was estimated to be £6738 (95% CI = £6297-7172), with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). CONCLUSIONS: Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%.

Heroin on trial: systematic review and meta-analysis of randomised trials of diamorphine-prescribing as treatment for refractory heroin addiction†.

BACKGROUND: Supervised injectable heroin (SIH) treatment has emerged over the past 15 years as an intensive treatment for entrenched heroin users who have not responded to standard treatments such as oral methadone maintenance treatment (MMT) or residential rehabilitation. AIMS: To synthesise published findings for treatment with SIH for refractory heroin-dependence through systematic review and meta-analysis, and to examine the political and scientific response to these findings. METHOD: Randomised controlled trials (RCTs) of SIH treatment were identified through database searching, and random effects pooled efficacy was estimated for SIH treatment. Methodological quality was assessed according to criteria set out by the Cochrane Collaboration. RESULTS: Six RCTs met the inclusion criteria for analysis. Across the trials, SIH treatment improved treatment outcome, i.e. greater reduction in the use of illicit 'street' heroin in patients receiving SIH treatment compared with control groups (most often receiving MMT). CONCLUSIONS: SIH is found to be an effective way of treating heroin dependence refractory to standard treatment. SIH may be less safe than MMT and therefore requires more clinical attention to manage greater safety issues. This intensive intervention is for a patient population previously considered unresponsive to treatment. Inclusion of this low-volume, high-intensity treatment can now improve the impact of comprehensive healthcare provision.

Drug use, health and social outcomes of hard-to-treat heroin addicts receiving supervised injectable opiate treatment: secondary outcomes from the Randomized Injectable Opioid Treatment Trial (RIOTT).

AIMS: The Randomized Injectable Opioid Treatment Trial (RIOTT) compared supervised injectable heroin (SIH) and supervised injectable methadone (SIM) with optimized oral methadone (OOM) (ISRCTN0133807). Heroin addicts (previously unresponsive to treatment) made significant reductions in street heroin use at 6 months when treated with SIH. We now examine secondary outcomes. DESIGN: Multi-site randomized controlled trial (RCT) comparing SIH versus OOM and SIM versus OOM. SETTING: Three supervised injectable opiate clinics in England. PARTICIPANTS: Chronic refractory heroin addicts continuing to inject street heroin virtually daily despite oral substitution treatment (n = 127), randomized to either SIH(n = 43), SIM(n = 42) or OOM(n = 42). All received high levels of medical and psychosocial support. SECONDARY OUTCOMES: wider drug use, crime, health and social functioning at 6 months. FINDINGS: At 6 months, no significant differences were found between treatment groups in wider drug use (crack/cocaine, benzodiazepines, alcohol), physical and mental health (SF-36) or social functioning. Within each treatment group, significant reductions were observed in crime [SIH = odds ratio (OR) 0.05; P < 0.001; SIM = OR 0.11; P = 0.002; OOM = OR 0.11; P = 0.003] and money spent per week on illicit drugs (SIH = mean change £-289.43; P < 0.001; SIM = mean change £-183.41; P < 0.001; OOM = mean change £-162.80; P < 0.001), with SIH significantly more likely to have reduced money spent on illicit drugs versus OOM (mean difference £-92.04; P < 0.001). Significant improvements were seen in physical health for SIH and SIM (SIH = mean change 3.97; P = 0.008; SIM = mean change 4.73; P = 0.002) and mental health for OOM (mean change 6.04; P = 0.013). CONCLUSIONS: Supervised injectable heroin treatment and supervised injectable methadone treatment showed no clearly identified benefit over optimized oral methadone in terms of wider drug use, crime, physical and mental health within a 6-month period, despite reducing street heroin use to a greater extent. However, all interventions were associated with improvements in these outcomes.

Use of contingency management incentives to improve completion of hepatitis B vaccination in people undergoing treatment for heroin dependence: a cluster randomised trial.

BACKGROUND: Poor adherence to treatment diminishes its individual and public health benefit. Financial incentives, provided on the condition of treatment attendance, could address this problem. Injecting drug users are a high-risk group for hepatitis B virus (HBV) infection and transmission, but adherence to vaccination programmes is poor. We aimed to assess whether contingency management delivered in routine clinical practice increased the completion of HBV vaccination in individuals receiving opioid substitution therapy. METHODS: In our cluster randomised controlled trial, we enrolled participants at 12 National Health Service drug treatment services in the UK that provided opioid substitution therapy and nurse-led HBV vaccination with a super-accelerated schedule (vaccination days 0, 7, and 21). Clusters were randomly allocated 1:1:1 to provide vaccination without incentive (treatment as usual), with fixed value contingency management (three £10 vouchers), or escalating value contingency management (£5, £10, and £15 vouchers). Both contingency management schedules rewarded on-time attendance at appointments. The primary outcome was completion of clinically appropriate HBV vaccination within 28 days. We also did sensitivity analyses that examined vaccination completion with full adherence to appointment times and within a 3 month window. The trial is registered with Current Controlled Trials, number ISRCTN72794493. FINDINGS: Between March 16, 2011, and April 26, 2012, we enrolled 210 eligible participants. Compared with six (9%) of 67 participants treated as usual, 35 (45%) of 78 participants in the fixed value contingency management group met the primary outcome measure (odds ratio 12·1, 95% CI 3·7-39·9; p<0·0001), as did 32 (49%) of 65 participants in the escalating value contingency management group (14·0, 4·2-46·2; p<0·0001). These differences remained significant with sensitivity analyses. INTERPRETATION: Modest financial incentives delivered in routine clinical practice significantly improve adherence to, and completion of, HBV vaccination programmes in patients receiving opioid substitution therapy. Achievement of this improvement in routine clinical practice should now prompt actual implementation. Drug treatment providers should employ contingency management to promote adherence to vaccination programmes. The effectiveness of routine use of contingency management to achieve long-term behaviour change remains unknown. FUNDING: National Institute for Health Research (RP-PG-0707-10149).

Treatment expectations and satisfaction of treatment-refractory opioid-dependent patients in RIOTT, the Randomised Injectable Opiate Treatment Trial, the UK's first supervised injectable maintenance clinics.

INTRODUCTION AND AIMS: The study investigates patients' pre-treatment expectations of, and post-treatment satisfaction with, supervised injectable opiate treatment delivered within UK's first such clinics within the Randomised Injectable Opiate Treatment Trial (RIOTT) (ISRCTN0133807). DESIGN AND METHODS: Data were collected from 127 chronic heroin addicts recruited to RIOTT and randomised to receive supervised injectable (heroin or methadone) treatment or optimised oral maintenance treatment at supervised injectable maintenance clinics in London, Darlington and Brighton. RESULTS: Of 127 RIOTT patients, 113 (89%) provided responses to structured enquiry about treatment expectations, and 94 (74%) subsequent responses about treatment satisfaction (at six months). Patients were hoping that injectable heroin treatment would: reduce substance misuse (81%); help achieve normality, routine and structure (16%); and increase education and work prospects (15%). At six months, an area of treatment satisfaction most commonly reported by all three trial groups was reduced substance misuse (supervised injectable heroin 59%, supervised injectable methadone 56%, optimised oral methadone 54%). Most found supervision acceptable, but some desired modifications were also identified. DISCUSSION AND CONCLUSIONS: Patients previously considered non-responsive to treatment appear to have similar treatment expectations and aspirations as other drug users in treatment. Supervised injectable opioid treatment patients consistently reported treatment satisfaction but also that more could be done to optimise aspects of current arrangement. This raised the challenging issue of the extent to which opinions of patients need to be taken into consideration in shaping future treatment provision. Future research may need to examine the extent of expectations 'fit' and the relationship between treatment sought and received.

Cost-effectiveness of injectable opioid treatment v. oral methadone for chronic heroin addiction.

BACKGROUND: Despite evidence of the effectiveness of injectable opioid treatment compared with oral methadone for chronic heroin addiction, the additional cost of injectable treatment is considerable, and cost-effectiveness uncertain. AIMS: To compare the cost-effectiveness of supervised injectable heroin and injectable methadone with optimised oral methadone for chronic refractory heroin addiction. METHOD: Multisite, open-label, randomised controlled trial. Outcomes were assessed in terms of quality-adjusted life-years (QALYs). Economic perspective included health, social services and criminal justice resources. RESULTS: Intervention costs over 26 weeks were significantly higher for injectable heroin (mean £8995 v. £4674 injectable methadone and £2596 oral methadone; P<0.0001). Costs overall were highest for oral methadone (mean £15 805 v. £13 410 injectable methadone and £10 945 injectable heroin; P = n.s.) due to higher costs of criminal activity. In cost-effectiveness analysis, oral methadone was dominated by injectable heroin and injectable methadone (more expensive and less effective). At willingness to pay of £30 000 per QALY, there is a higher probability of injectable methadone being more cost-effective (80%) than injectable heroin. CONCLUSIONS: Injectable opioid treatments are more cost-effective than optimised oral methadone for chronic refractory heroin addiction. The choice between supervised injectable heroin and injectable methadone is less clear. There is currently evidence to suggest superior effectiveness of injectable heroin but at a cost that policy makers may find unacceptable. Future research should consider the use of decision analytic techniques to model expected costs and benefits of the treatments over the longer term.

Supervised injectable heroin or injectable methadone versus optimised oral methadone as treatment for chronic heroin addicts in England after persistent failure in orthodox treatment (RIOTT): a randomised trial.

BACKGROUND: Some heroin addicts persistently fail to benefit from conventional treatments. We aimed to compare the effectiveness of supervised injectable treatment with medicinal heroin (diamorphine or diacetylmorphine) or supervised injectable methadone versus optimised oral methadone for chronic heroin addiction. METHODS: In this multisite, open-label, randomised controlled trial, we enrolled chronic heroin addicts who were receiving conventional oral treatment (>or=6 months), but continued to inject street heroin regularly (>or=50% of days in preceding 3 months). Randomisation by minimisation was used to assign patients to receive supervised injectable methadone, supervised injectable heroin, or optimised oral methadone. Treatment was provided for 26 weeks in three supervised injecting clinics in England. Primary outcome was 50% or more of negative specimens for street heroin on weekly urinalysis during weeks 14-26. Primary analysis was by intention to treat; data were adjusted for centre, regular crack use at baseline, and treatment with optimised oral methadone at baseline. Percentages were calculated with Rubin's rules and were then used to estimate numbers of patients in the multiple imputed samples. This study is registered, ISRCTN01338071. FINDINGS: Of 301 patients screened, 127 were enrolled and randomly allocated to receive injectable methadone (n=42 patients), injectable heroin (n=43), or oral methadone (n=42); all patients were included in the primary analysis. At 26 weeks, 80% (n=101) patients remained in assigned treatment: 81% (n=34) on injectable methadone, 88% (n=38) on injectable heroin, and 69% (n=29) on oral methadone. Patients on injectable heroin were significantly more likely to have achieved the primary outcome (72% [n=31]) than were those on oral methadone (27% [n=11], OR 7.42, 95% CI 2.69-20.46, p<0.0001; adjusted: 66% [n=28] vs 19% [n=8], 8.17, 2.88-23.16, p<0.0001), with number needed to treat of 2.17 (95% CI 1.60-3.97). For injectable methadone (39% [n=16]; adjusted: 30% [n=14]) versus oral methadone, the difference was not significant (OR 1.74, 95% CI 0.66-4.60, p=0.264; adjusted: 1.79, 0.67-4.82, p=0.249). For injectable heroin versus injectable methadone, a significant difference was recorded (4.26, 1.63-11.14, p=0.003; adjusted: 4.57, 1.71-12.19, p=0.002), but the study was not powered for this comparison. Differences were evident within the first 6 weeks of treatment. INTERPRETATION: Treatment with supervised injectable heroin leads to significantly lower use of street heroin than does supervised injectable methadone or optimised oral methadone. UK Government proposals should be rolled out to support the positive response that can be achieved with heroin maintenance treatment for previously unresponsive chronic heroin addicts. FUNDING: Community Fund (Big Lottery) Research section, through Action on Addiction.