Trazodone for Sleep Disturbance in Early Alcohol Recovery (SIESTA)

May 11, 2010 updated by: Rhode Island Hospital

Trazodone for Sleep Disturbance - Early Alcohol Recovery

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.)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Trazodone
Drug: Trazodone
50 to 150 mg qhs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent days abstinent from alcohol (PDA)
Time Frame: 12 and 24 weeks
12 and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
sleep quality
Time Frame: 12 and 24 weeks
12 and 24 weeks
Drinks per drinking day
Time Frame: 12 and 24 weeks
12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Peter D. Friedmann, MD, MPH, Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 19, 2001

First Submitted That Met QC Criteria

November 19, 2001

First Posted (Estimate)

November 20, 2001

Study Record Updates

Last Update Posted (Estimate)

May 13, 2010

Last Update Submitted That Met QC Criteria

May 11, 2010

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAAFRI13243
  • R01AA013243 (U.S. NIH Grant/Contract)
  • NIH grant R01 AA013243

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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