Insomnia and Drug Relapse Risk

Opiate Addiction Clinical Trial

Official title:

Insomnia and Drug Relapse Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253890
• Other study ID #: RO1 DA 020479
• Secondary ID: R01DA020479-01
• Status: Completed
• Phase: Phase 3
• First received: November 10, 2005
• Last updated: October 22, 2013
• Start date: October 2005
• Est. completion date: May 2010

Study information

• Verified date: October 2013
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Recent methadone maintenance enrollment

• Sleep complaints as measured by the Pittsburgh Sleep Quality Index (PSQI)

• No medical contraindications to trazodone

Exclusion Criteria:

• Methadone maintenance enrollment not recent

• No sleep complaints as measured by the PSQI

• Medical contraindications to trazodone

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

• Opiate Addiction
• Poor Quality Sleep

Intervention

Drug:
• Trazodone
50 mg 1-3 capsules at bedtime for 3 months
• Placebo
1-3 at bedtime

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality, as Measured by Total Sleep Time	Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.	Baseline to 1-month	No