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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 medication

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018418
Enrollment
100
Registered
2019-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F112- Opioid dependence

Interventions

Intervention1: TRAZODONE: TRAZODONE STARTING DOSE OF 50 MG TO A MAXIMUM OF 150 MG TABLETS ORALLY FOR A MAXIMUM PERIOD OF 6 WEEKS. PATIENTS DOSE WILL BE TITRATED DURING WEEKLY ASSESSMENT BY PHARMACIS

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Male gender 2 Age 18 to 60 years 3 Literate (able to read and write) 4 Registered in NDDTC OPD/community clinics 5 Initiated on buprenorphine (BPN) / BPN-Naloxone (BPN-N) at least three months prior to intervention for treatment of Opioid Dependence Syndrome 6 Maintained on a stable dose (dose change not more than two milligram per day) of buprenorphine/buprenorphine-naloxone for last one month 7 Adherent on BPN / BPN-N (for at least 50% occasions in last one month) 8 Total scores on Pittsburgh Sleep Quality Index > 5

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1 History of co-morbid psychiatric illnesses, except sleep disorders (as per MINI-7 Screen) in last one month. 2 Use of any other non-prescribed psychoactive substances, except nicotine, cannabis, alcohol and caffeine, in last one month 3 Cannabis and alcohol use in â??high-riskâ?? category (as per WHO-ASSIST score) 4 On other psychotropic medications (except buprenorphine/BPN-N) in the past one month 5 Diagnosed case of chronic physical illnesses (such as HTN, Coronary Artery Disease, Chronic Kidney Disease, Chronic Liver Disease, Endocrine diseases including DM, COPD, etc.)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
â?¢ To assess factors associated with changes in sleep disturbances (if any) among opioid-dependent patients maintained on buprenorphineTimepoint: BASELINE TO 6 WEEKS—

Countries

India

Contacts

Public ContactPIYUSH KUMAR GOYAL

CONSULTANT

drrvrao@gmail.com9810323164

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026