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Insomnia and Drug Relapse Risk

Primary Purpose

Poor Quality Sleep, Opiate Addiction

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Trazodone

Placebo

About this trial

This is an interventional treatment trial for Poor Quality Sleep focused on measuring sleep quality, methadone, substance use

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Trazodone

Placebo

Arm Description

50-150mg (50mg capsules) at bedtime for 90 days

1-3 capsules at bedtime for 90 days

Outcomes

Primary Outcome Measures

Sleep Quality, as Measured by Total Sleep Time

Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

Secondary Outcome Measures

Full Information

NCT ID

NCT00253890

First Posted

November 10, 2005

Last Updated

October 22, 2013

Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00253890

Brief Title

Insomnia and Drug Relapse Risk

Official Title

Insomnia and Drug Relapse Risk

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purposes of this study are: to evaluate the relationship between subjective complaints of sleep and objective measures of sleep quality, as measured through polysomnography, and to evaluate the efficacy of trazodone, as compared to placebo, in individuals early in methadone maintenance.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poor Quality Sleep, Opiate Addiction

Keywords

sleep quality, methadone, substance use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

137 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trazodone

Arm Type

Active Comparator

Arm Description

50-150mg (50mg capsules) at bedtime for 90 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

1-3 capsules at bedtime for 90 days

Intervention Type

Drug

Intervention Name(s)

Trazodone

Other Intervention Name(s)

Desyrel, Oleptro, Beneficat, Deprax, Desirel, Molipaxin, Thombran, Trazorel, Trialodine, Trittico, Mesyrel

Intervention Description

50 mg 1-3 capsules at bedtime for 3 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar pill

Intervention Description

1-3 at bedtime

Primary Outcome Measure Information:

Title

Sleep Quality, as Measured by Total Sleep Time

Description

Number of minutes spent sleeping during sleep period, as measured by daily sleep diary.

Time Frame

Baseline to 1-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael D Stein, MD

Organizational Affiliation

Rhode Island Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Rogers Griffith, MD

Organizational Affiliation

The Miriam Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Butler Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20155590

Citation

Kurth ME, Sharkey KM, Millman RP, Corso RP, Stein MD. Insomnia among methadone-maintained individuals: the feasibility of collecting home polysomnographic recordings. J Addict Dis. 2009 Jul;28(3):219-25. doi: 10.1080/10550880903014155.

Results Reference

derived

Learn more about this trial

Insomnia and Drug Relapse Risk

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