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| [ Print-friendly version ] |
| Positive Reinforcement targeting Abstinence In Substance misusE (PRAISE) |
| ISRCTN | ISRCTN01591254 |
| DOI | 10.1186/ISRCTN01591254 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Positive Reinforcement targeting Abstinence In Substance misusE (PRAISE) |
| Scientific title | Cluster randomised controlled trial of two Contingency Management schedules targeting treatment attendance or abstinence from street heroin use in people treated for heroin dependence |
| Acronym | PRAISe |
| Serial number at source | 6113 |
| Study hypothesis |
The aim of the trial is to implement, observe and assess the acceptability, feasibility and clinical and cost effectiveness of CM strategies to improve treatment attendance and abstinence from heroin.
This trial is part of a larger programme of research. The trial is a multi-centre stratified cluster randomised trial (CRT) measuring OST outcomes with one of: (a) TAU + 12 week schedule of weekly keywork appointments (no praise or voucher); (b) TAU + 12 week positive reinforcement (praise &voucher) for attending scheduled weekly keywork appointments; (c) TAU + 12 week positive reinforcement (praise and voucher) for providing a weekly urine sample negative for opiates. We will compare results for the primary outcome at the 3rd month (weeks 9-12) in all 3 treatment conditions. Each of the 33 clinics will be their own cluster. Each clinic/cluster will be randomly assigned to one of the above trial arms (ie. 20 participants per cluster, 11 clusters per arm, 220 participants in each arm and 660 in total). After week 12, there will be complete cessation of rewards. In the follow-up phase (weeks 13-24) all participants will receive identical care with no CM. All primary and secondary outcomes at 12 weeks will be reassessed at 24 weeks for all participants. In addition, the number of opiate-negative urine test results during weeks 21-24 will be assessed. Both CM schedules will offer the same valve of incentive over a 12 week period, but with different target behaviours (attendance vs abstinence). Incentives will be vouchers exchangeable at general supermarket chains. The outcome of the trial will be determined by the mean number of urine tests results negative for opiates during weeks 9-12. The trial data will also be used to model differential costs of the two CM schedules vs current practice. A process evaluation will be conducted alongside the trial, in order to understand the implementation, delivery, fidelity and outcome of the trial intervention. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=6113 |
| Lay summary | Lay summary under review 2 |
| Ethics approval | NRES Committee South East Coast - Surrey, 25 July 2012 ref: 12/LO/0910 |
| Study design | Randomised interventional trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Mental Health Research Network; Addictions |
| Participants - inclusion criteria |
1. Aged >18 years
2. Seeking new episode of OST treatment 3. Agree to 12 week treatment programme promoting abstinence 4. Regular users of street heroin in preceding month (self report 15/30 use and all UDS in past 4 weeks opiate positive) 5. Opiate dependent (meeting ICD-10 criteria) and at liberty to participate in the study for 24 weeks 6. Willing and able to provide informed consent 7. Male or female |
| Participants - exclusion criteria |
1. Pregnant or breastfeeding
2. Active mental health problem 3. Patients referred into treatment under a criminal justice order 4. Patients who cannot read English AND require the service of an interpreter to understand a brief oral description of the study |
| Anticipated start date | 12/11/2012 |
| Anticipated end date | 30/04/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | UK Sample Size: 660; Description: 33 clusters each with 20 participants |
| Interventions |
Contingency Management, A psychological intervention using positive reinforcement (usually in the form of praise and vouchers which can be exchangeable for goods ) to encourage engagement with treatment and to promote behaviours congruent with treatment goals. This intervention is delivered as an adjunct to existing opiate substitute treatment. Group A 12 x weekly keywork session; Group B 12 x weekly keywork session with CM (attendance); Group C 12 x weekly keywork session with CM (attendance & urine screens).
Follow Up Length: 3 months |
| Primary outcome measure(s) | Mean number of opiate negative urine test results during weeks 9-12 |
| Secondary outcome measure(s) |
1. Retention in treatment at the 3-month and 6-month follow-up
2. Urine test results at the 6-month follow-up (3 months post-CM) 3. Indices of physical, psychological and social well-being 4. Health economic and criminal justice outcomes |
| Sources of funding | NIHR Programme Grants for Applied Research ref: RP-PG-0707-10149 (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Nicola Metrebian |
| Address |
Addictions Department
Institute of Psychiatry Kings College London 4 Windsor Walk Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| nicola.metrebian@kcl.ac.uk | |
| Sponsor | South London & Maudsley NHS Foundation Trust and Kings College London (UK) |
| Address |
c/o Ms Jenny Liebscher
SLaM R&D Office Room W1.08 Institute of Psychiatry De Crespigny Park Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| Sponsor website: | http://www.slam.nhs.uk/ |
| Date applied | 19/11/2012 |
| Last edited | 19/11/2012 |
| Date ISRCTN assigned | 19/11/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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