ACTRN12606000100594
Not yet recruiting
Phase 3
The safety and efficacy of baclofen for alcohol dependence: a double-blind randomised placebo-controlled trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Alcohol Dependence
- Sponsor
- Sydney South West Area Health Service
- Enrollment
- 42
- Status
- Not yet recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •DMS\-IV criteria for alcohol dependence; Meets criteria for current heavy drinking; Can provide informed written consent; 3\-days abstinence prior to treatment; Desires abstinence or to greatly reduce alcohol consumption; Has stable residence and can provide collateral contact details.
Exclusion Criteria
- •Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern; Clinically significant psychiatric illness or substance use disorder other than alcohol or nicotine dependence or cannabis abuse; Concurrent use of any psyhotropic medication (except subjects on stable antidepressant doses \> 2 months); Concurrent use of anticonvulsants, insulin or oral hypoglycemics, History of complicated alcohol withdrawal; Extremely abnormal LFTs; Women who are pregnant or breadfeeding; Requiring inpatient or more intense outpatient treatment for alcohol dependence; Court\-mandated participation in alcohol treatment or impending incarceration.
Outcomes
Primary Outcomes
Not specified
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