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Trazodone for Sleep Disturbance in Early Alcohol Recovery (SIESTA)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 20, 2001
Last Update Posted: May 13, 2010
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.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Rhode Island Hospital
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 Intervention Phase
Alcoholism Drug: Trazodone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trazodone for Sleep Disturbance - Early Alcohol Recovery

Resource links provided by NLM:

Further study details as provided by Rhode Island Hospital:

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

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

Enrollment: 173
Study Start Date: June 2002
Study Completion Date: June 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trazodone Drug: Trazodone
50 to 150 mg qhs
Placebo Comparator: Placebo Drug: Placebo


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).
  Contacts and Locations
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 ClinicalTrials.gov 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
  More Information

Responsible Party: Peter Friedmann, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00027053     History of Changes
Other Study ID Numbers: NIAAAFRI13243
R01AA013243 ( U.S. NIH Grant/Contract )
NIH grant R01 AA013243
First Submitted: November 19, 2001
First Posted: November 20, 2001
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