Trazodone an antidepressant also used for treatment of sleep disorders for treating sleep problems in patients who are addicted to opioids and are on medication buprenorphine for treatment of opioid addiction when compared to placebo medicatio
- Conditions
- Health Condition 1: F112- Opioid dependence
- Registration Number
- CTRI/2019/04/018418
- Lead Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1Male gender
2Age 18 to 60 years
3Literate (able to read and write)
4Registered in NDDTC OPD/community clinics
5Initiated on buprenorphine (BPN) / BPN-Naloxone (BPN-N) at least three months prior to intervention for treatment of Opioid Dependence Syndrome
6Maintained on a stable dose (dose change not more than two milligram per day) of buprenorphine/buprenorphine-naloxone for last one month
7Adherent on BPN / BPN-N (for at least 50% occasions in last one month)
8Total scores on Pittsburgh Sleep Quality Index > 5
1History of co-morbid psychiatric illnesses, except sleep disorders (as per MINI-7 Screen) in last one month.
2Use of any other non-prescribed psychoactive substances, except nicotine, cannabis, alcohol and caffeine, in last one month
3Cannabis and alcohol use in â??high-riskâ?? category (as per WHO-ASSIST score)
4On other psychotropic medications (except buprenorphine/BPN-N) in the past one month
5Diagnosed case of chronic physical illnesses (such as HTN, Coronary Artery Disease, Chronic Kidney Disease, Chronic Liver Disease, Endocrine diseases including DM, COPD, etc.)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢To assess effect of trazodone in improvement of sleep disturbances among opioid-dependent patients maintained on buprenorphine compared to placeboTimepoint: â?¢BASELINE TO 6 WEEKS
- Secondary Outcome Measures
Name Time Method â?¢To assess factors associated with changes in sleep disturbances (if any) among opioid-dependent patients maintained on buprenorphineTimepoint: BASELINE TO 6 WEEKS