search
Back to results

Trazodone for Sleep Disturbance in Early Alcohol Recovery (SIESTA)

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trazodone
Placebo
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring alcoholism, alcohol dependence, trazadone, sleep

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trazodone

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percent days abstinent from alcohol (PDA)

Secondary Outcome Measures

sleep quality
Drinks per drinking day

Full Information

First Posted
November 19, 2001
Last Updated
May 11, 2010
Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00027053
Brief Title
Trazodone for Sleep Disturbance in Early Alcohol Recovery
Acronym
SIESTA
Official Title
Trazodone for Sleep Disturbance - Early Alcohol Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcoholism, alcohol dependence, trazadone, sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trazodone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Trazodone
Intervention Description
50 to 150 mg qhs
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent days abstinent from alcohol (PDA)
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
sleep quality
Time Frame
12 and 24 weeks
Title
Drinks per drinking day
Time Frame
12 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter D. Friedmann, MD, MPH
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18616688
Citation
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. Epub 2008 Jul 8.
Results Reference
result

Learn more about this trial

Trazodone for Sleep Disturbance in Early Alcohol Recovery

We'll reach out to this number within 24 hrs