Trazodone for Sleep Disturbance in Early Alcohol Recovery | NCT00027053

Studies
Trazodone for Sleep Disturbance in Early Alcohol Recovery

NCT00027053

Sponsor

Rhode Island Hospital

Status

Completed

Last Update Posted

May 13, 2010Estimated

Enrollment

173Actual

Phase

Phase 2

Conditions

Alcoholism

Interventions

Trazodone
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01AA013243	U.S. NIH Grant/Contract		View source
NIH grant R01 AA013243

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2002

Primary Completion Date

Jan 2006Actual

Completion Date

Jun 2006Actual

First Submitted Date

Nov 19, 2001

First Submission Date that Met QC Criteria

Nov 19, 2001

First Posted Date

Nov 20, 2001Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2010

Last Update Posted Date

May 13, 2010Estimated

Name	Class
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

173Actual

Label	Type	Description	Intervention Names
Trazodone	Experimental		Drug: Trazodone
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Trazodone	Drug	50 to 150 mg qhs	Trazodone
Placebo

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

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

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Peter D. Friedmann, MD, MPH	Rhode Island Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital		Providence	Rhode Island	02903	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18616688	Result	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.

ID	Term
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011728	Pyridones