The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in the treatment of nicotine-dependence in overweight and obese subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
All subjects are to complete a 4 week titration period at which time subjects will be titrated up to a maintenance level of study drug. Subjects will then take the maintenance dose of study drug for an additional 20 weeks.
During the study, subjects will receive ancillary therapy including counseling on smoking cessation, diet and exercise.
Pharmacology Research Institute
Encino, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
Assess rates of smoking cessation defined by continuous abstinence.
Time frame: 12 weeks
To assess the percent change from baseline in total body weight during the entire study
Time frame: Baseline to endpoint
To assess the rates of smoking cessation as measured by expired CO levels <10 ppm
Time frame: 12 and 24 weeks
To assess the change from baseline in tobacco use from baseline as measured by a tobacco use diary
Time frame: Baseline to endpoint
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