CTRI/2019/04/018418
Not yet recruiting
未知
Trazodone for sleep disturbance in opioid dependent patients maintained on buprenorphine:a double blind placebo controlled trial
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: F112- Opioid dependence
- Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Not specified
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