Baclofen for Smoking Cessation in a Non-Psychiatric Population

Phase 2

Terminated

• Conditions: Nicotine Dependence
• Interventions: Drug: Baclofen 30 mg/day; Drug: placebo pill; Drug: Baclofen 60 mg/day

• Registration Number: NCT01228994
• Lead Sponsor: Centre for Addiction and Mental Health

Brief 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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Male or female adults (18 years or older).
• Meet DSM-IV criteria for nicotine dependence,
• Smoke ≥10 cigarettes/day,
• Baseline FTND score ≥4, CO level ≥10,
• have had at least one failed quit attempt in the past and are motivated to quit within 30 days of initial intake.
• No previous use of medication for smoking cessation in 1 month prior to randomization.
• BMI between 15 and 40 inclusive.

Exclusion Criteria

• Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder, or a current or past history of bipolar disorder or schizophrenia
• Have a past history of major depression, with historical evidence of suicidal or homicidal behaviour, or psychotic symptom,
• Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc) in 3 months prior to randomization
• Demonstrate serious medical conditions, unstable cardiovascular disease, significant blood abnormalities)
• Are pregnant, are trying to become pregnant or are currently breastfeeding
• Baclofen hypersensitivity .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Baclofen 30 mg/day	Baclofen 30 mg/day	Baclofen medication
Placebo pill	placebo pill	placebo pill
Baclofen 60 mg/day	Baclofen 60 mg/day	Baclofen medication high dose

Primary Outcome Measures

Name	Time	Method
Smoking abstinence for 7 days at end of treatment	end of treatment week 10	At end of treatment subjects will report smoking consumption for past 7 days. Subject are considered abstinent based on self report and verfied by CO level (\<10 PPM)
Abstinent rate: last four weeks of trial	last 4 weeks of trial (week 7 to 10)	subjects report cigarette consumption during the last 4 weeks of the clinical trial.; abstinence rates are verifed by CO \< 10 PPM
abstinence rate: for past 7 days at 6 month followup	6 month followup	Subject are asked to attend a 6 month followup. At this time subjects will be asked to report their cigarette consumption for the past 7 days.; abstinence is based on this self report and verified by CO levels \<10 PPM

Secondary Outcome Measures

Name	Time	Method
Tiffany Questionnaire of Smoking Urges	screen, week 1,4,7,10, abd 6 month followup	tobacco craving is monitored at different time points of the trial
Minnesota Nicotine Withdrawal Scale	Screen, week 1,4,7,10 and 6 month followup	This scale assesses symptoms of tobacco withdrawal including nicotine craving, irritability, anziety, difficulty conentrating, restlessness, headaches, fatigue, increased appetite, weight gain, and insomnia.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health- 33 Russell St; 🇨🇦 Toronto, Ontario, Canada