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Trazodone for Sleep Disturbance in Early Alcohol Recovery
This study has been completed.
Study NCT00027053   Information provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First Received: November 19, 2001   Last Updated: March 3, 2006   History of Changes

November 19, 2001
March 3, 2006
June 2002
 
Percent days abstinent from alcohol (PDA)
Same as current
Complete list of historical versions of study NCT00027053 on ClinicalTrials.gov Archive Site
Correlation of sleep architecture findings with sleep quality and recurrent drinking
Same as current
 
Trazodone for Sleep Disturbance in Early Alcohol Recovery
Trazodone for Sleep Disturbance - Early Alcohol Recovery

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.)

 
Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Alcoholism
Drug: trazodone (Desyrel)
 
Friedmann PD, Rose JS, Swift R, Stout RL, Millman RP, Stein MD. Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2008 Sep;32(9):1652-60. Epub 2008 Jul 8.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
266
January 2006
 

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).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00027053
 
NIAAAFRI13243, NIH grant R01 AA013243
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
 
Principal Investigator: Peter D. Friedmann, MD, MPH Rhode Island Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP