NCT00027053

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.)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2001

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

May 13, 2010

Status Verified

March 1, 2006

Enrollment Period

3.6 years

First QC Date

November 19, 2001

Last Update Submit

May 11, 2010

Conditions

Alcoholism

Keywords

alcoholismalcohol dependencetrazadonesleep

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent from alcohol (PDA)

    12 and 24 weeks

Secondary Outcomes (2)

  • sleep quality

    12 and 24 weeks

  • Drinks per drinking day

    12 and 24 weeks

Study Arms (2)

Trazodone

EXPERIMENTAL
Drug: Trazodone

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TrazodoneDRUG

50 to 150 mg qhs

Trazodone
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related 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. Epub 2008 Jul 8.

    PMID: 18616688RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridines

Study Officials

  • Peter D. Friedmann, MD, MPH

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 19, 2001

First Posted

November 20, 2001

Study Start

June 1, 2002

Primary Completion

January 1, 2006

Study Completion

June 1, 2006

Last Updated

May 13, 2010

Record last verified: 2006-03

Locations

US(1)