Clinical Trials Logo

Clinical Trial Summary

The purposes of this study are:

1. to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and

2. to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.


Clinical Trial Description

Individuals new to methadone maintenance will be asked to participate in this 6-month, double-blind, randomized control trial. All participants will complete a baseline interview, a medical screening and follow-up interviews at 1, 3 and 6-months post-baseline. These interviews take approximately 60 minutes, and survey various areas of the participants' experiences, including basic demographic information, mood, sleep and substance use areas. All participants will also be asked to complete a 2-night sleep monitoring at the time of the baseline interview and again at the 1-month follow-up interview. Participants will also receive study medication; half of the participants will receive a placebo medication, and the other half will receive Trazodone, a widely-prescribed, well-tolerated, low side-effect medication. Neither the participant nor the study staff will know which medication the participant is taking while the participant is actively enrolled in the study. This information can be available to the participant at the end of his/her study participation. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00253890
Study type Interventional
Source Butler Hospital
Contact
Status Completed
Phase Phase 3
Start date October 2005
Completion date May 2010

See also
  Status Clinical Trial Phase
Completed NCT02539823 - Acute and Short-term Effects of CBD on Cue-induced Craving in Drug-abstinent Heroin-dependent Humans Phase 2
Recruiting NCT01934751 - Effectiveness of a Hospital Addiction Service in Treating Opioid and Alcohol Addiction N/A
Completed NCT00913770 - Models of Screening, Brief Intervention With a Facilitated Referral to Treatment (SBIRT) for Opioid Patients in the Emergency Department N/A
Completed NCT00929253 - Efficacy of Computer Delivered Community Reinforcement Approach (CRA) (Bup II) N/A
Terminated NCT02741076 - Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain Phase 4
Completed NCT03015597 - Pilot Study of Contingency Management for Smoking Cessation N/A
Completed NCT02571400 - Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study N/A
Terminated NCT00552578 - Buprenorphine as a Treatment in Opiate Dependent Pain Patients Phase 4
Completed NCT02667158 - A Survey to Eval the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion
Completed NCT02667210 - Study to Eval Relation Btw Doctor/Pharmacy Shopping & Outcomes of Misuse, Diversion, Abuse, Addiction by Med Rec Review
Active, not recruiting NCT01021566 - Opiate Detoxification Using the Combined Hemoperfusion-hemodialysis Phase 3
Withdrawn NCT01015066 - Comparison of Buprenorphine/Naloxone With Naltrexone in Opioid Dependent Adolescents Phase 4
Completed NCT02660619 - Validation of PRISM-5-Op, Measure Of Addiction To Prescription Opioid Medication
Active, not recruiting NCT02751762 - A Prospective Investigation of the Risks of Opioid Misuse, Abuse, and Addiction Among Patients Treated With Opioids for the Treatment of Chronic Pain
Completed NCT02657148 - Immediate Postpartum Nexplanon Placement in Opioid Dependent Women
Completed NCT02362256 - The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism N/A
Completed NCT01605539 - Acute and Short-term Effects of Cannabidiol Admin on Cue-induced Craving in Drug-abstinent Heroin Dependent Humans Phase 2
Completed NCT00204243 - Naltrexone Implants vs. MMT Among Inmates in the Norwegian Correctional Services Phase 2
Completed NCT02667262 - An Observational Study to Develop Algorithms for Identifying Opioid Abuse and Addiction Based on Admin Claims Data
Completed NCT00829777 - Safety Study of Intravenous 6β-Naltrexol (AIKO-150) in Opioid-Dependent Subjects Phase 1