Trazodone for Sleep Disturbance in Early Alcohol Recovery

Study Overview
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Brief Summary
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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.)

Official Title
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Trazodone for Sleep Disturbance - Early Alcohol Recovery

Conditions
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Alcoholism

Intervention / Treatment
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* Drug: Trazodone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trazodone<br> | Drug: Trazodone<br>* 50 to 150 mg qhs<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent days abstinent from alcohol (PDA) |  | 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep quality |  | 12 and 24 weeks | 
| Drinks per drinking day |  | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcoholism, alcohol dependence, trazadone, sleep