| November 19, 2001 |
| March 3, 2006 |
| June 2002 |
| |
| Percent days abstinent from alcohol (PDA) |
| Same as current |
| Complete list of historical versions of study NCT00027053 on ClinicalTrials.gov Archive Site |
| Correlation of sleep architecture findings with sleep quality and recurrent drinking |
| Same as current |
| |
| Trazodone for Sleep Disturbance in Early Alcohol Recovery |
| 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.) |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
| Alcoholism |
| Drug: trazodone (Desyrel) |
| |
| 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. Epub 2008 Jul 8. |
| |
| Completed |
| 266 |
| January 2006 |
|
Inclusion Criteria:
- Completed the alcohol detoxification program at SSTAR.
- 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).
|
| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00027053 |
|
| NIAAAFRI13243, NIH grant R01 AA013243 |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|
| Principal Investigator: |
Peter D. Friedmann, MD, MPH |
Rhode Island Hospital |
|
|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| March 2006 |