Health Condition 1: F122- Cannabis dependence Health Condition 2: F112- Opioid dependence
Conditions
Interventions
Intervention1: Tab Baclofen Sustained Release: Baclofen SR starting dose of 20 mg increased to 20 mg 2 tab over 4 days and then to 20 mg 3 tabs over next 3 days. 60 mg to be taken orally for the next
Sponsors
All India Institute Of Medical sciences
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess if baclofen is able to decrease the number of days of cannabis use in Buprenorphine maintained patients with comorbid cannabis use disorder compared to placebo.Timepoint: baseline, 4 weeks, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess if baclofen is able to decrease cannabis-related craving & withdrawal scores in Buprenorphine maintained patients with comorbid cannabis use disorder compared to placebo.Timepoint: Baseline, 4 weeks, 8 weeks | — |
Countries
India
Contacts
Public ContactDr Shreya Shukla
All India Institute Of Medical Sciences, New Delhi
Outcome results
None listed