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The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) Prisons Project: An open label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for prison primary care detoxification from either heroin or methadone - LEEDS Prisons Project

Phase 1
Conditions
Opiate addiction (detoxification from illicit opiates)
Registration Number
EUCTR2005-001195-13-GB
Lead Sponsor
niversity of Leeds
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
340
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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Contraindications to methadone or buprenorphine (subutex)
Co-exisiting acute medical conditions requiring emergency admission to hospital care 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
Previously been randomised into this trial

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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