Nicotine Dependence
Conditions
Keywords
smoking cessation treatment, baclofen, Smoking cessation counselling
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.
Interventions
DRUGBaclofen 30 mg/day
Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease
DRUGplacebo pill
placebo pill
DRUGBaclofen 60 mg/day
baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease
Sponsors
Canadian Tobacco Control Research Initiative
Centre for Addiction and Mental Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada
Outcome results
None listed