Baclofen for Smoking Cessation in a Non-Psychiatric Population (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.
|Nicotine Dependence||Drug: Baclofen 30 mg/day Drug: placebo pill Drug: Baclofen 60 mg/day||Phase 2|
|Study Design:||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|
- 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)
- 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
- 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
- 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
- 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.
|Study Start Date:||October 2010|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Baclofen 30 mg/day
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
Drug: 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228994
|Centre for Addiction and Mental Health- 33 Russell St|
|Toronto, Ontario, Canada, M5S2S1|
|Principal Investigator:||Bernard Le Foll, MD, PhD||Centre for Addiction and Mental Health|