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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01228994
Recruitment Status : Terminated (The study was terminated because of difficulties recruiting subjects.)
First Posted : October 27, 2010
Last Update Posted : September 12, 2013
Canadian Tobacco Control Research Initiative
Information provided by (Responsible Party):
Bernard Le Foll, 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Baclofen 30 mg/day Drug: placebo pill Drug: Baclofen 60 mg/day Phase 2

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  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen
Study Start Date : October 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
Drug Information available for: Baclofen

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 Name: 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 Name: Lioresal, Kemstro

Primary Outcome Measures :
  1. Smoking abstinence for 7 days at end of treatment [ Time Frame: 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)

  2. Abstinent rate: last four weeks of trial [ Time Frame: 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

  3. abstinence rate: for past 7 days at 6 month followup [ Time Frame: 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 :
  1. Tiffany Questionnaire of Smoking Urges [ Time Frame: screen, week 1,4,7,10, abd 6 month followup ]
    tobacco craving is monitored at different time points of the trial

  2. Minnesota Nicotine Withdrawal Scale [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01228994

Canada, Ontario
Centre for Addiction and Mental Health- 33 Russell St
Toronto, Ontario, Canada, M5S2S1
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Tobacco Control Research Initiative
Principal Investigator: Bernard Le Foll, MD, PhD Centre for Addiction and Mental Health

Additional Information:
Responsible Party: Bernard Le Foll, Prinicipal Investigator, Centre for Addiction and Mental Health Identifier: NCT01228994     History of Changes
Other Study ID Numbers: 1632009
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: September 12, 2013
Last Verified: September 2013

Keywords provided by Bernard Le Foll, Centre for Addiction and Mental Health:
smoking cessation treatment
Smoking cessation counselling

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action