Trazodone for Sleep Disturbance in Early Alcohol Recovery

Phase 2

Completed

• Conditions: Alcoholism
• Interventions: Drug: Placebo; Drug: Trazodone

• Registration Number: NCT00027053
• Lead Sponsor: Rhode Island Hospital

Brief Summary

This study is a randomized, double-blind clinical trial comparing trazodone (Desyrel) and placebo among sleep-disturbed, alcohol-dependent individuals shortly after discharge from an inpatient detoxification program. Subjects will undergo a baseline assessment and random assignment to trazodone or identical placebo for 12 weeks. All persons completing the alcohol detoxification at Stanley Street Treatment and Resources (SSTAR) will be screened. (SSTAR of Rhode Island provides detoxification services to non/underinsured persons of Rhode Island.)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2001-11-19
• Study First Submitted QC: 2001-11-19
• Study First Posted: 2001-11-20
• Study Start: 2002-06
• Primary Completion: 2006-01
• Status Verified: 2006-03
• Study Completion: 2006-06
• Last Update Submitted: 2010-05-11
• Last Update Posted: 2010-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

• Completed an alcohol detoxification program.
• Meets criteria for alcohol dependence.
• Meets criteria for sleep disturbance.
• If female of childbearing potential must be using adequate contraception.
• Has a location to which they will return after the initial research interview and a person they regularly contact.
• Speaks English sufficiently to understand instructions and assessment.

Exclusion Criteria

• Meets criteria for substance dependence for sedative/hypnotic drugs, stimulants, cocaine or opiates, or of organic brain disorder, bipolar disorder, schizophrenia, schizoaffective, schizophreniform, or paranoid disorder, or major depression.
• Current suicidality.
• Use of psychotropic, antidepressant, anxiolytic or antidipsogenic medication.
• Inability or refusal to terminate the use of proerectile agents, herbal medications or sleep medication for the study period.
• The presence of contraindications to the study medications, including pregnancy/lactation, ischemic heart disease, cardiac arrhythmias, priapism or hypotension.
• Presence of comorbid medical conditions associated with sleep disturbance including obstructive sleep apnea, poorly controlled diabetes mellitus or emphysema.
• Evidence of neuropsychological dysfunction.
• Probation/parole requirements that might interfere with participation in study.
• Inability to identify at least one contact person.
• Living on the street after detoxification (homeless persons living in a shelter, halfway house or other residence will not be excluded).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Trazodone	Trazodone	-

Primary Outcome Measures

Name	Time	Method
Percent days abstinent from alcohol (PDA)	12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
sleep quality	12 and 24 weeks
Drinks per drinking day	12 and 24 weeks

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States