Trazodone for sleep disturbance in opioid dependent patients maintained on buprenorphine:a double blind placebo controlled trial

ALL INDIA INSTITUTE OF MEDICAL SCIENCES0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.)

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