Clinical trial NCT01228994: Baclofen for Smoking Cessation in a Non-Psychiatric Population
Official title: Testing the GABAergic Hypothesis of Nicotine Dependence: a Randomized Clinical Trial of Baclofen
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nicotine Dependence
Keywords: smoking cessation treatment
baclofen
Smoking cessation counselling
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Canadian Tobacco Control Research Initiative
First posted: 2010-10-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 .

Primary outcomes:
measure: Smoking abstinence for 7 days at end of treatment
timeFrame: end of treatment week 10
measure: Abstinent rate: last four weeks of trial
timeFrame: last 4 weeks of trial (week 7 to 10)
measure: abstinence rate: for past 7 days at 6 month followup
timeFrame: 6 month followup
Secondary outcomes:
measure: Tiffany Questionnaire of Smoking Urges
timeFrame: screen, week 1,4,7,10, abd 6 month followup
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Screen, week 1,4,7,10 and 6 month followup
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health- 33 Russell St
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: