Baclofen for Smoking Cessation in a Non-Psychiatric Population (Baclofen)

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

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.

Study Overview

• Status: Terminated
• Conditions: Nicotine Dependence
• Intervention / Treatment: Drug: Baclofen 30 mg/day; Drug: placebo pill; Drug: Baclofen 60 mg/day

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S2S1
      • Centre for Addiction and Mental Health- 33 Russell St

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Baclofen 30 mg/day; Baclofen medication	Drug: Baclofen 30 mg/day; Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease; Other Names: Lioresal, Kemstro
Placebo Comparator: Placebo pill; placebo pill	Drug: placebo pill; placebo pill
Active Comparator: Baclofen 60 mg/day; Baclofen medication high dose	Drug: Baclofen 60 mg/day; baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease; Other Names: Lioresal, Kemstro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking abstinence for 7 days at end of treatment	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)	end of treatment week 10
Abstinent rate: last four weeks of trial	subjects report cigarette consumption during the last 4 weeks of the clinical trial. abstinence rates are verifed by CO < 10 PPM	last 4 weeks of trial (week 7 to 10)
abstinence rate: for past 7 days at 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	6 month followup

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: Canadian Tobacco Control Research Initiative

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 25, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): September 12, 2013
• Last Update Submitted That Met QC Criteria: September 11, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: baclofen; smoking cessation treatment; Smoking cessation counselling
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: 1632009