Opiate detoxification study
| ISRCTN | ISRCTN14951861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14951861 |
| Secondary identifying numbers | N0120148502 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 06/04/2009
- 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
Dr Duncan Raistrick
Scientific
Scientific
Addictions Unit
19 Springfield Mount
Woodhouse
Leeds
LS2 9NG
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To investigate whether buprenorphine opiate detoxification regime can be considered to be at least as clinically effective as a lofexidine regime, which was taken at the reference treatment. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Drug addiction |
| Intervention | The study was a randomised controlled trial (RCT) using a non-inferiority approach. Non-inferiority is demonstrated if, within a 95% confidence interval, buprenorphine performs within a preset tolerance limit of clinically acceptable differences in outcomes, completion rates between the two treatments. Individual ready for heroin detoxification were given information about the trial and invited to participate. Consenting participants were then randomised to one of the two treatments. Detoxification was undertaken in a specialist outpatient clinic according to pre-defined protocols. The detoxification procedure required that this was an open label trial. The primary outcome was whether or not an individual completed the detoxification. Completion of the planned detoxification was taken to be an objective marker of both the acceptability of the pharmacotherapy and also the effectiveness of the detoxification procedure in the clinic. Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure. The difference in completion proportions between the two treatments was then tested to determine whether or not the treatments could be considered clinically equivalent. Data were also collected for individuals who declined randomisation and instead chose their treatment. Additional secondary outcome measures were substance use, dependence, psychological health, social satisfaction and treatment satisfaction. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Buprenorphine, lofexidine |
| Primary outcome measure | The primary outcome was whether or not an individual completed the detoxification. |
| Secondary outcome measures | Abstinence at one-month follow-up was taken as an indicator of overall treatment effectiveness and was used as a secondary outcome measure. |
| Overall study start date | 01/05/2000 |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Individual ready for heroin detoxification who agreed to take part in the trial. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addictions Unit
Leeds
LS2 9NG
United Kingdom
LS2 9NG
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leeds Mental Health Teaching NHS Trust (UK) NHS R&D Support Funding
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2005 | Yes | No |
