The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project: An open label pragmatic randomised controlled trial comparing the efficacy of differing therapeutic agents for prison primary care detoxification from illicit opiates
- Conditions
- Problematic use of illicit opiates requiring medical detoxificationMental and Behavioural DisordersOpioid dependence
- Registration Number
- ISRCTN58823759
- Lead Sponsor
- niversity of Leeds (UK)
- Brief Summary
2009 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/19602218 protocol 2011 Results article in https://www.ncbi.nlm.nih.gov/pubmed/22137413 results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 340
Male or female, 18-65 years old, using illicit opiates as confirmed by a urine test at first assessment, remaining in the prison estate for longer than 28 days
Contraindications to buprenorphine or methadone,
co-existing acute medical conditions requiring emergency admission to hospital so precluding detoxification in the prison setting, currently undergoing detoxification from other addictive drugs whereby concurrent detoxification from illicit opiates would not be clinically indicated, women who are pregnant or breastfeeding, prisoners previously randomised into this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abstinence of illicit opiates 5 days post completion of detoxification as indicated by a urine test
- Secondary Outcome Measures
Name Time Method Adverse events recorded during the detoxification period: inappropriate use of prescribed medication, overdose, admission to prison healthcare, accident and emergency (A&E) or hospital. Abstinence at 1, 3 and 6 months post detoxification. At 1, 3 and 6 months: evidence and volume of service utilisation.