drugset / Trial / NCT01980706

Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

NCT01980706

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.

Timeline

Start
2013-12-12
Primary completion
2017-10-26
Completion
2017-10-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Baclofen Small molecule 30 mg
Comparator Baclofen Small molecule 90 mg

Indications