Clinical trial NCT00027053: Trazodone for Sleep Disturbance in Early Alcohol Recovery
Official title: Trazodone for Sleep Disturbance - Early Alcohol Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Keywords: alcoholism
alcohol dependence
trazadone
sleep
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2001-11-20
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)


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).

Primary outcomes:
measure: Percent days abstinent from alcohol (PDA)
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: sleep quality
timeFrame: 12 and 24 weeks
measure: Drinks per drinking day
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Peter D. Friedmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.