Baclofen for Smoking Cessation in a Non-Psychiatric Population

This study has been terminated.
(The study was terminated because of difficulties recruiting subjects.)
Sponsor:
Collaborator:
Canadian Tobacco Control Research Initiative
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01228994
First received: October 25, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Nicotine Dependence
Drug: Baclofen 30 mg/day
Drug: placebo pill
Drug: Baclofen 60 mg/day
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Smoking abstinence for 7 days at end of treatment [ Time Frame: end of treatment week 10 ] [ Designated as safety issue: No ]
    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 [ Time Frame: last 4 weeks of trial (week 7 to 10) ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 month followup ] [ Designated as safety issue: No ]

    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:
  • Tiffany Questionnaire of Smoking Urges [ Time Frame: screen, week 1,4,7,10, abd 6 month followup ] [ Designated as safety issue: No ]
    tobacco craving is monitored at different time points of the trial

  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Screen, week 1,4,7,10 and 6 month followup ] [ Designated as safety issue: No ]
    This scale assesses symptoms of tobacco withdrawal including nicotine craving, irritability, anziety, difficulty conentrating, restlessness, headaches, fatigue, increased appetite, weight gain, and insomnia.


Enrollment: 6
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228994

Locations
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
Investigators
Principal Investigator: Bernard Le Foll, MD, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Bernard Le Foll, Prinicipal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01228994     History of Changes
Other Study ID Numbers: 1632009
Study First Received: October 25, 2010
Last Updated: September 11, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
smoking cessation treatment
baclofen
Smoking cessation counselling

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Baclofen
Contraceptives, Oral
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
GABA-B Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 18, 2014