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

ISRCTN	ISRCTN58823759
DOI	https://doi.org/10.1186/ISRCTN58823759
Protocol serial number	3
Sponsor	University of Leeds (UK)
Funder	Department of Health Forensic Mental Health Research Funding Scheme 2004 (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Clive Adams
Scientific

Dept. of Psychiatry
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study acronym	LEEDS
Study objectives	To evaluate whether buprenorphine or methadone given openly to illicit opiate users presenting for detoxification in the UK NHS prison setting helps achieve abstinence at completion of regime
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Problematic use of illicit opiates requiring medical detoxification
Intervention	Buprenorphine or methadone
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Buprenorphine and methadone
Primary outcome measure(s)	Abstinence of illicit opiates 5 days post completion of detoxification as indicated by a urine test
Key secondary outcome measure(s)	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.
Completion date	01/11/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	340
Key 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
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	01/11/2007

Dept. of Psychiatry

Leeds
LS2 9LT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2011		Yes	No
Protocol article	protocol	14/07/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

24/01/2023: The study setting has been updated from ‘Not specified’.
16/01/2018: Internal review.