Trazodone for Sleep Disturbance in Early Alcohol Recovery (SIESTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00027053
Recruitment Status : Completed
First Posted : November 20, 2001
Last Update Posted : May 13, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Rhode Island Hospital

Brief 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.)

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Trazodone Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trazodone for Sleep Disturbance - Early Alcohol Recovery
Study Start Date : June 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Trazodone Drug: Trazodone
50 to 150 mg qhs
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Percent days abstinent from alcohol (PDA) [ Time Frame: 12 and 24 weeks ]

Secondary Outcome Measures :
  1. sleep quality [ Time Frame: 12 and 24 weeks ]
  2. Drinks per drinking day [ Time Frame: 12 and 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00027053

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Peter D. Friedmann, MD, MPH Rhode Island Hospital

Publications of Results:
Responsible Party: Peter Friedmann, Rhode Island Hospital Identifier: NCT00027053     History of Changes
Other Study ID Numbers: NIAAAFRI13243
R01AA013243 ( U.S. NIH Grant/Contract )
NIH grant R01 AA013243
First Posted: November 20, 2001    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: March 2006

Keywords provided by Rhode Island Hospital:
alcohol dependence

Additional relevant MeSH terms:
Sleep Wake Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents