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Home > "T" Clinical Trials Conditions > Trazodone for Sleep Disturbance in Early Alcohol Recovery  Trazodone for Sleep Disturbance in Early Alcohol Recovery
Trazodone for Sleep Disturbance in Early Alcohol Recovery
For Condition: Alcoholism
Status: Recruiting
Sponsor(s): National Institute on Alcohol Abuse and Alcoholism (NIAAA) ,
Synopsis: 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.)
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry 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).
Total Enrollment: 266
Location and Contact Information:
Rhode Island Hospital *Recruiting*
Providence, Rhode Island, 02903
United States
Recruiting Dr. Friedman 410-444-3347
Additional Information:
Study ID Numbers: NIAAAFRI13243;
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027053
Other Alcoholism Studies:
1. Naltrexone Treatment for Alcoholism
2. Naltrexone, Craving, and Drinking
3. Pharmacologic Relapse Prevention for Alcoholic Smokers
4. Naltrexone Maintenance Treatment of Alcoholism
5. Treatment for Alcoholism and Post-Traumatic Stress Disorder (naltrexone)
Related Studies:
Other Alcoholism Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Trazodone for Sleep Disturbance in Early Alcohol Recovery
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