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Clinical Trials/ACTRN12606000100594
ACTRN12606000100594
Not yet recruiting
Phase 3

The safety and efficacy of baclofen for alcohol dependence: a double-blind randomised placebo-controlled trial

Sydney South West Area Health Service0 sites42 target enrollmentMarch 15, 2006

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.

Registry
who.int
Start Date
March 15, 2006
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

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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