Trazodone for Sleep Disturbance in Early Alcohol Recovery - Full Text View

Trazodone for Sleep Disturbance in Early Alcohol Recovery (SIESTA)

This study has been completed.

First Received on November 19, 2001. Last Updated on May 11, 2010 History of Changes

Sponsor:	Rhode Island Hospital
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	Rhode Island Hospital
ClinicalTrials.gov Identifier:	NCT00027053

Purpose

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 II

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:

MedlinePlus related topics: Alcoholism Sleep Disorders

Drug Information available for: Ethanol Trazodone Trazodone hydrochloride

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027053

Locations

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)

Investigators

Principal Investigator:

Peter D. Friedmann, MD, MPH

Rhode Island Hospital

More Information

Publications:

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.

Responsible Party:	Peter Friedmann, Rhode Island Hospital
ClinicalTrials.gov 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:

alcoholism
alcohol dependence
trazadone
sleep

Additional relevant MeSH terms:

Alcoholism
Sleep Disorders
Dyssomnias
Parasomnias
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on February 09, 2012