Trazodone for Sleep Disturbance in Early Alcohol Recovery
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism
Intervention: trazodone (Desyrel) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Official(s) and/or principal investigator(s):
Peter D. Friedmann, MD, MPH, Principal Investigator, Affiliation: Rhode Island Hospital
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.)
Clinical Details
Official title: Trazodone for Sleep Disturbance - Early Alcohol Recovery
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Primary outcome: Percent days abstinent from alcohol (PDA)
Secondary outcome: Correlation of sleep architecture findings with sleep quality and recurrent drinking
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): 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).
Locations and Contacts
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Additional Information
Starting date: June 2002
Ending date: January 2006
Last updated: March 3, 2006
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