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 |
| Secondary identifying numbers | 3 |
- Submission date
- 16/08/2005
- Registration date
- 15/09/2005
- Last edited
- 24/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Clive Adams
Scientific
Scientific
Dept. of Psychiatry
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Prison/detention |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Buprenorphine and methadone |
| Primary outcome measure | Abstinence of illicit opiates 5 days post completion of detoxification as indicated by a urine test |
| Secondary outcome measures | 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. |
| Overall study start date | 01/11/2005 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept. of Psychiatry
Leeds
LS2 9LT
United Kingdom
LS2 9LT
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
School of Medicine
24 Hyde Terrace
Leeds
LS2 9LN
England
United Kingdom
"ROR" |
https://ror.org/024mrxd33 |
|---|
Funders
Funder type
Government
Department of Health Forensic Mental Health Research Funding Scheme 2004 (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 14/07/2009 | Yes | No | |
| Results article | results | 01/12/2011 | Yes | No |
Editorial Notes
24/01/2023: The study setting has been updated from ‘Not specified’.
16/01/2018: Internal review.
