Trazodone for Sleep Disturbance in Early Alcohol Recovery

Alcoholism Clinical Trial

— SIESTA  

Official title:

Trazodone for Sleep Disturbance - Early Alcohol Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027053
• Other study ID #: NIAAAFRI13243
• Secondary ID: R01AA013243NIH g
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2001
• Last updated: May 11, 2010
• Start date: June 2002
• Est. completion date: June 2006

Study information

• Verified date: March 2006
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: June 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Dyssomnias
• Parasomnias
• Sleep Disorders

Intervention

Drug:
• Trazodone
50 to 150 mg qhs
• Placebo

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. doi: 10.1111/j.1530-0277.2008.00742.x. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent days abstinent from alcohol (PDA)		12 and 24 weeks	No
Secondary	sleep quality		12 and 24 weeks	No
Secondary	Drinks per drinking day		12 and 24 weeks	No