Phase 4
Completed N=134
Sertraline Pharmacotherapy for Alcoholism Subtypes
Alcoholism
Source: ClinicalTrials.gov NCT00368550 ↗
Enrolled (actual)
134
Serious AEs
2.2%
Results posted
Aug 2010
Primary outcomePrimary: Number of Days on Which Subjects Drank — 37.0; 33.8 days
Summary
The purpose of this study is to determine whether Sertraline, compared to placebo, is effective in the treatment of alcohol dependence as a function of the subtype of alcoholic patient being treated. This involved administering sertraline (to a maximum of 200 mg/day) or an inactive placebo for a 14-week treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days on Which Subjects Drank |
37.0; 33.8 | — |
| SECONDARY Number of Days of Heavy Drinking (Defined as Days on Which Women Drank >= 4 Drinks and Men Drank >= 5 Drinks) |
31.9; 26.4 | — |
| SECONDARY Change in the Level of Alcohol-related Problems |
6.0; 9.0 | — |
Eligibility Criteria
Inclusion Criteria
- Current episode (i.e., in the preceding month) of alcohol dependence defined by Diagnostic and Statistical Manual of Mental Disorders 4th ed (DSM-IV) criteria
- 18-65 years of age
- Abstinent from alcohol for a period of at least 3 days prior to baseline research assessment
- Able to read English and complete study evaluations
- Male, or if female, without active reproductive potential
- Participants will have signed informed consent
Exclusion Criteria
- Currently meets criteria for dependence on a psychoactive substance other than alcohol and nicotine
- Regular use of psychoactive drugs including anxiolytics and antidepressants
- Current use of disulfiram or naltrexone
- Current major depression or psychosis (or other severe psychiatric disability e.g., suicidality, current mania)
- Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac pathology, which in the opinion of the evaluating physician would preclude the patient from study adherence or be of potential harm to the subject
Data sourced from ClinicalTrials.gov (NCT00368550). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.