drugset / Trial / NCT01228994

Baclofen for Smoking Cessation in a Non-Psychiatric Population

NCT01228994 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures. The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group. The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

Timeline

Start
2010-10
Primary completion
2012-08
Completion
2012-08

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated because of difficulties recruiting subjects.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Baclofen Small molecule 30 mg —
Comparator Baclofen Small molecule 60 mg —

Indications