Baclofen for maintenance treatment of opioid dependence: A randomised double-blind placebo-controlled clinical trial
| ISRCTN | ISRCTN32121581 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32121581 |
| Protocol serial number | G36 |
| Sponsor | Roozbeh Addiction Department (Iran) |
| Funder | Roozbeh Addiction Department (Iran) (ref: G36) |
- Submission date
- 14/11/2003
- Registration date
- 17/11/2003
- Last edited
- 01/10/2007
- 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 Seyed Mohammad Assadi
Scientific
Scientific
Roozbeh Psychiatric Hospital
South Kargar Avenue
Tehran
13337
Iran
| Phone | +98 (0)21 542222 |
|---|---|
| assadism@sina.tums.ac.ir |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Opioid dependence |
| Intervention | A total of 40 opioid-dependent patients were detoxified and randomly assigned to receive baclofen (20 mg three times a day [t.i.d.]) or placebo (in identical-appearing tablets t.i.d.) in a 12-week, double blind, parallel-group trial. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Baclofen |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 40 |
| Key inclusion criteria | Subjects were eligible for the study if they: 1. Met DSM-IV criteria for opioid dependence 2. Were detoxified at our addiction clinic 3. Were between 18 and 60 years of age 4. Gave written informed consent for participation in the study Opioid dependence (according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV] criteria). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 01/11/2002 |
Locations
Countries of recruitment
- Iran
Study participating centre
Roozbeh Psychiatric Hospital
Tehran
13337
Iran
13337
Iran
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 18/11/2003 | Yes | No |
