se of baclofen for cannabis use in patients maintained on Buprenorphine: double-blind placebo-controlled randomised controlled trial

Not Applicable

• Conditions: Health Condition 1: F122- Cannabis dependenceHealth Condition 2: F112- Opioid dependence

• Registration Number: CTRI/2023/10/059294
• Lead Sponsor: All India Institute Of Medical sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Male gender

2.Age 18 to 50 years

3.Suffering from Opioid Dependence Syndrome and registered in NDDTC OPD/community clinics

4.Initiated on buprenorphine (BPN) / BPN-Naloxone (BPN-N) AT LEAST THREE months for treatment of opioid dependence syndrome before inclusion in the study

5.Maintained on a stable dose (dose change not more than two milligram) of buprenorphine/buprenorphine-naloxone for last one month

6.Adherent on BPN / BPN-N (for at least 50 percent occasions in last one month)

7.Total scores on ASSIST (Cannabis) more than or equal to 4

8.Cannabis use for at least 15 days in the last one month

9.Literate (able to read and write)

10.Willing to give informed consent to participate in the study

Exclusion Criteria

1.History of co-morbid psychiatric illnesses (as per clinical interview)

2.WHO- ASSIST scores more than or equal to 10 for alcohol or more than or equal to 4 for other substances (except tobacco/cannabis)

3.Use of any other non-prescribed psychoactive substances, except nicotine and cannabis , in last one month.

4.On other non prescribed psychotropic medications in the past one month

5.Presence of any condition that precludes the use of Baclofen

6.Unable to participate in the interview

Study & Design

• Study Type: Interventional
• Study Design: Not specified