The effectiveness of adjunctive Medication Management and Contingency Management to enhance adherence to medications for relapse prevention in alcohol dependence
A community pharmacist will hand out small vouchers to people recovering from alcohol dependence if they show up for appointments and take their medication as prescribed. This trial tests whether adding medication management by a pharmacist, with or without these small incentives, helps people stick with acamprosate—a drug that reduces the urge to drink after detoxification. Many people relapse because they stop taking the medication. Standard support alone often fails to keep them adherent. If the approach works, it could give the NHS a practical, low-cost way to cut relapse rates without requiring specialist staff. The intervention runs through community pharmacies and uses modest rewards, making it scalable across the UK. Reduced relapse would mean fewer hospital admissions, less alcohol-related harm, and lower costs for health and social care. The economic analysis also considers impacts on criminal justice and productivity, so the findings could reshape how alcohol dependence is managed in routine primary care.
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Design: 3-arm, pragmatic, randomised controlled, parallel group clinical trial of strategies to enhance adherence to acamprosate (AC) for alcohol dependence. Standard support (SS), SS with adjunctive medication management (SS+MM), SS and MM with adjunctive contingency management (SS+MM+CM). Outcome assessment will be at 3, 6 and 12 months post randomisation. Setting: 5 NHS trusts (London (South and North-West), Humberside, Southampton and Birmingham) and community pharmacies. Population: Detoxified alcohol dependent adults, suitable for prescription of AC, willing and able to provide informed consent. Inclusion: Aged >=18, ICD-10 alcohol dependence, completed medically assisted alcohol detoxification, commencing a prescription for AC. Exclusion: Severe physical/mental illness identified by the treating clinicians, current dependence on other substances (except nicotine), participation in another trial, current use of other relapse prevention medication. Heath technologies: MM provided by community pharmacists (weekly for 6 weeks and then fortnightly for 6 weeks and then monthly up to 3 months). MM+CM: Small incentives (vouchers) will be provided to reinforce adherence with MM contingent on attendance at appointment with the community pharmacist. Primary outcome: Percentage of prescribed medication taken estimated using Medication Events Monitoring System (MEMS) and verified using pill count and self-report at 6 months post randomisation. Secondary outcomes: Percentage of prescribed medication taken, estimated by self-report at 12 month follow-up. Alcohol consumption measured by TLFB-90: % days abstinent; units of alcohol per drinking day; time to first drink; relapse to any drinking; and relapse to heavy drinking (8+/6+ UK units (1 unit = 8g alcohol) for males/females on a single occasion). Alcohol related problems (APQ), alcohol craving (AUQ), Participants beliefs about medications (BMQ), the therapeutic relationship with the care giver (STAR), health related quality of life (EQ-5D-5L), Adult Service Use Schedule, costs of control and trial interventions, adverse events. Economic analysis: Analysis of the costs and effects of MM with or without CM for alcohol dependence compared to SS. The primary economic perspective will be the health and social care provider perspective. Broader perspectives will be considered in sensitivity analyses (i.e. criminal justice contacts and criminal activity, productivity losses, patient and family costs). Sample size: Differential allocation of the order of 2:1:1 with twice as many being allocated to the SS group than the intervention groups. A clinically important difference in adherence to medication is estimated as an effect size of the order of 0.3. To estimate this difference using power of 80%, alpha 0.05 with a 2 sided test requires 524 analysed at 6 months across the three groups. Allowing for attrition of 30%, less than observed in other trials in similar populations, requires a total sample size at allocation of 748; 374 allocated to SS, and 187 each to SS+MM and SS+MM+CM. Timetable: Months 0-8: Ethical, R&D, regulatory approvals, adaptation of CM procedure, staff training. Months 9-11 Pilot study. Months 12-33: Recruitment for main trial (average 6 participants/centre each month), Months 12-36: 3 month follow-up, Months 18–42: 6 month follow-up, Months 24–45: 12 month follow-up, Months 46-48: Analysis, report writing, dissemination.
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