Positive reinforcement targeting abstinence in substance misuse (PRAISe): Study protocol for a Cluster RCT & process evaluation of contingency management

Abstract

There are approximately 256,000 heroin and other opiate users in England of whom 155,000 are in treatment for heroin (or opiate) addiction. The majority of people in treatment receive opiate substitution treatment (OST) (methadone and buprenorphine). However, OST suffers from high attrition and persistent heroin use even whilst in treatment. Contingency management (CM) is a psychological intervention based on the principles of operant conditioning. It is delivered as an adjunct to existing evidence based treatments to amplify patient benefit and involves the systematic application of positive reinforcement (financial or material incentives) to promote behaviours consistent with treatment goals. With an international evidence base for CM, NICE recommended that CM be implemented in UK drug treatment settings alongside OST to target attendance and the reduction of illicit drug use. While there was a growing evidence base for CM, there had been no examination of its delivery in UK NHS addiction services. The PRAISe trial evaluates the feasibility, acceptability, clinical and cost effectiveness of CM in UK addiction services. It is a cluster randomised controlled effectiveness trial of CM (praise and financial incentives) targeted at either abstinence from opiates or attendance at treatment sessions versus no CM among individuals receiving OST. The trial includes an economic evaluation which explores the relative costs and cost effectiveness of the two CM intervention strategies compared to TAU and an embedded process evaluation to identify contextual factors and causal mechanisms associated with variations in outcome. This study will inform UK drug treatment policy and practice. Trial registration ISRCTN 01591254.

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

“…Each cluster was randomly assigned to additionally provide either: i) positive reinforcement in the form of a £10 voucher given to participants at each weekly appointment for both on-time attendance and abstinence from opiates using an instant cup test (CM Abstinence group); ii) positive reinforcement in the form of a £10 voucher given at each weekly appointment for on-time attendance only (CM Attendance group); or no CM. The main clinical results (9) and design details (10) are reported elsewhere.…”

Contingency Management Intervention in Quitting Substance Abuse: A Literature Review

“…Metrebian et al [10]. conducted research in the UK and suggested that CM intervention should be included in the drug treatments in the UK.…”

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

“…We employed a pragmatic cluster randomised controlled trial design described elsewhere. 18 The unit of randomisation was the drug clinic (cluster) rather than individual participant. This was for three reasons: (1) to reduce the likelihood of contamination if staff were delivering and patients receiving different interventions at the same drug clinic; (2) to reduce interpatient contamination as patients themselves constitute a local social network; and (3) to reduce the risk of low recruitment, poor compliance and high dropout within treatment as usual (TAU) arm if participants receiving TAU were denied an incentive offered to others in the same clinic.…”

“…More detail is provided in the protocol. 18 Lussier et al 8 estimated a mean weighted effect size of 0.39 from three studies with an opiate use outcome measure (CM vs control). For a two-sided test, alpha=0.05, 5% attrition, 80% power to detect an effect size of 0.39, 111 participants per group were required.…”