Condition category
Mental and Behavioural Disorders
Date applied
14/11/2003
Date assigned
17/11/2003
Last edited
01/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Seyed Mohammad Assadi

ORCID ID

Contact details

Roozbeh Psychiatric Hospital
South Kargar Avenue
Tehran
13337
Iran
+98 (0)21 542222
assadism@sina.tums.ac.ir

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G36

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Baclofen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

01/11/2002

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/11/2001

Recruitment end date

01/11/2002

Locations

Countries of recruitment

Iran

Trial participating centre

Roozbeh Psychiatric Hospital
Tehran
13337
Iran

Sponsor information

Organisation

Roozbeh Addiction Department (Iran)

Sponsor details

Roozbeh Psychiatric Hospital
South Kargar Avenue
Tehran
13337
Iran
+98 (0)21 542222
a3057@sina.tums.ac.ir

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Roozbeh Addiction Department (Iran) (ref: G36)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=14624703

Publication citations

  1. Results

    Assadi SM, Radgoodarzi R, Ahmadi-Abhari SA, Baclofen for maintenance treatment of opioid dependence: a randomized double-blind placebo-controlled clinical trial [ISRCTN32121581]., BMC Psychiatry, 2003, 3, 16, doi: 10.1186/1471-244X-3-16.

Additional files

Editorial Notes