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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00027053 |
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Date of registration:
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19/11/2001 |
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Primary sponsor: |
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Public title:
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Trazodone for Sleep Disturbance in Early Alcohol Recovery
SIESTA |
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Scientific title:
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Trazodone for Sleep Disturbance - Early Alcohol Recovery |
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Date of first enrolment:
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June 2002 |
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Target sample size:
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173 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00027053 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter D. Friedmann, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rhode Island Hospital |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alcoholism
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Intervention(s)
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Drug: Placebo
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Drug: Trazodone
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Primary Outcome(s)
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Percent days abstinent from alcohol (PDA)
[Time Frame: 12 and 24 weeks]
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Secondary Outcome(s)
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Drinks per drinking day
[Time Frame: 12 and 24 weeks]
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sleep quality
[Time Frame: 12 and 24 weeks]
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Secondary ID(s)
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NIAAAFRI13243
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NIH grant R01 AA013243
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R01AA013243
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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