Status:
TERMINATED
Baclofen for Smoking Cessation in a Non-Psychiatric Population
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Canadian Tobacco Control Research Initiative
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 a...
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-depende...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01228994
Start Date
October 1 2010
End Date
August 1 2012
Last Update
September 12 2013
Active Locations (1)
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1
Centre for Addiction and Mental Health- 33 Russell St
Toronto, Ontario, Canada, M5S2S1