NCT01228994

Baclofen for Smoking Cessation in a Non-Psychiatric Population

Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will test a new medication strategy designed to help smokers quit. It will evaluate Baclofen, a drug currently approved and available in Canada as a myorelaxant. Forty five nicotine-dependent smokers will enroll in this study. Fifteen will receive placebo (inactive pill), fifteen will receive baclofen 30 mg/day, and fifteen will receive baclofen 60 mg/day. Once enrolled, subjects will visit CAMH on a weekly basis for assessment of smoking behaviour, a brief health check (vitals, BP and AE screening), delivery of brief individual smoking cessation counselling, and collection of breath, blood and urine samples (as scheduled) to a) measure levels of nicotine and its metabolites, b) conduct pregnancy and tox testing. The medication phase of this study lasts 12 weeks. Two follow-up visits will be scheduled at week 13 and at six months after trial completion.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Baclofen 30 mg/day	Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease
DRUG	placebo pill	placebo pill
DRUG	Baclofen 60 mg/day	baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-10-27
• Last updated: 2013-09-12

Locations

1 site across 1 country: Canada