Trazodone for Sleep Disturbance in Early Alcohol Recovery (SIESTA)

This study has been completed.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Rhode Island Hospital Identifier:
First received: November 19, 2001
Last updated: May 11, 2010
Last verified: March 2006
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
Drug: Trazodone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sleep quality [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
  • Drinks per drinking day [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00027053     History of Changes
Other Study ID Numbers: NIAAAFRI13243  R01AA013243  NIH grant R01 AA013243 
Study First Received: November 19, 2001
Last Updated: May 11, 2010
Health Authority: United States: Federal Government

Keywords provided by Rhode Island Hospital:
alcohol dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nervous System Diseases
Sleep Wake Disorders
Substance-Related Disorders
Anti-Anxiety Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Tranquilizing Agents processed this record on May 26, 2016