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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN58823759
Enrollment
340
Registered
2005-09-15
Start date
2005-11-01
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Problematic use of illicit opiates requiring medical detoxification Mental and Behavioural Disorders Opioid dependence

Interventions

Buprenorphine or methadone

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Abstinence of illicit opiates 5 days post completion of detoxification as indicated by a urine test

Secondary

MeasureTime frame
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.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 2, 2026