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Insomnia and Drug Relapse Risk

NCT ID: NCT00253890

Last Updated: 2013-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Poor Quality Sleep Opiate Addiction

Keywords

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sleep quality methadone substance use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trazodone

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

Group Type ACTIVE_COMPARATOR

Trazodone

Intervention Type DRUG

50 mg 1-3 capsules at bedtime for 3 months

Placebo

1-3 capsules at bedtime for 90 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1-3 at bedtime

Interventions

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Trazodone

50 mg 1-3 capsules at bedtime for 3 months

Intervention Type DRUG

Placebo

1-3 at bedtime

Intervention Type DRUG

Other Intervention Names

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Desyrel Oleptro Beneficat Deprax Desirel Molipaxin Thombran Trazorel Trialodine Trittico Mesyrel Sugar pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Stein, MD

Director, General Medicine Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael D Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Rogers Griffith, MD

Role: STUDY_DIRECTOR

The Miriam Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 20155590 (View on PubMed)

Other Identifiers

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R01DA020479-01

Identifier Type: NIH

Identifier Source: secondary_id

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R01DA020479

Identifier Type: NIH

Identifier Source: org_study_id

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