Trazodone |
Desyrel |
Clinical Trial: Trazodone for Sleep Disturbance in Early Alcohol Recovery
This study is currently recruiting patients.
|
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism | Drug: trazodone (Desyrel) | Phase II |
MedlinePlus related topics: Alcoholism
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control
Expected Total Enrollment: 266
Expected completion: August 2005
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Completed the alcohol detoxification program at SSTAR.
- 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).
Location and Contact Information
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
More Information
Record last reviewed: July 2003
Last Updated: October 13, 2004
Record first received: November 19, 2001
ClinicalTrials.gov Identifier: NCT00027053
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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