SIESTA: Trazodone for Sleep Disturbance in Early Alcohol Recovery

Sponsor

Rhode Island Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00027053

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

173

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.)

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: Trazodone Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

173 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Trazodone for Sleep Disturbance - Early Alcohol Recovery

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Jan 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trazodone	Drug: Trazodone 50 to 150 mg qhs
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: Trazodone

Drug: Trazodone

50 to 150 mg qhs

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Percent days abstinent from alcohol (PDA) [12 and 24 weeks]

Secondary Outcome Measures

sleep quality [12 and 24 weeks]
Drinks per drinking day [12 and 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).