Trazodone for Sleep Disturbance in Early Alcohol Recovery

This study has been completed.

First Received: November 19, 2001 Last Updated: March 3, 2006 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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 (Desyrel)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
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 National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Percent days abstinent from alcohol (PDA)

Secondary Outcome Measures:

Correlation of sleep architecture findings with sleep quality and recurrent drinking

Estimated Enrollment:	266
Study Start Date:	June 2002
Estimated Study Completion Date:	January 2006

Eligibility

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

Criteria

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).

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

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Peter D. Friedmann, MD, MPH

Rhode Island Hospital

More Information

No publications provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	NIAAAFRI13243, NIH grant R01 AA013243
Study First Received:	November 19, 2001
Last Updated:	March 3, 2006
ClinicalTrials.gov Identifier:	NCT00027053 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

alcoholism
alcohol dependence
trazadone
sleep

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Trazodone
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Sleep Disorders
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Alcohol-Related Disorders

Antidepressive Agents, Second-Generation
Antidepressive Agents
Tranquilizing Agents
Nervous System Diseases
Dyssomnias
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Alcoholism
Neurologic Manifestations
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010