The purpose of this research study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery. The intervention will be compared to a standard of care control group.
Be 18-65 years old.
Be actively considering bariatric surgery.
Smoke at least 5 cigarettes daily for the past 3 months.
Have a BMI ≥ 30.0 kg/m2.
Has an acute medical or psychiatric disorder that would make participation difficult or unsafe.
Has suicidal or homicidal ideation that requires immediate attention.
Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
Has evidence of a second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram that would preclude safe participation.
Parallel
Naltrexone hydrochloride
DrugParticipants will be given 50mg/day of Naltrexone for 4 months.
Bupropion Hydrochloride Extended-release
DrugParticipants will be given 300mg/day of Bupropion for 4 months. Bupropion will be taken twice daily (150mg in the morning, followed by 150mg in the late afternoon/early evening).
Cognitive-Behavioral Therapy
BehavioralParticipants will receive cognitive-behavioral therapy for weight loss and smoking cessation. Participants will meet with their assigned study clinician weekly for 60 minutes for 4 months.
Study enrollment to assess Feasibility
Number of participants enrolled out of participants screened.
Mean number treatment sessions attended to assess Feasibility
Mean number of treatment sessions attended.
Retention to assess Feasibility
Retention will be measured as the percent of participants that attend the post treatment assessment.
Treatment credibility to assess Acceptability
Treatment credibility will be assessed via self-report monthly. Acceptability measured as the percent of participants that agree the intervention is acceptable (0-100%, with higher scores being indicative of higher treatment credibility).
Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence
The Fagerstrom Test for Nicotine Dependence is a self-report measure that classifies level of nicotine dependence. Participants respond to a series of questions assessing time of first cigarette after waking, difficulty refraining from smoking in places where smoking is prohibited, and frequency of smoking. Total score range 0-10 with higher scores indication more nicotine dependence.
Depressive symptomatology, as measured by the Patient Health Questionnaire-9
The Patient Health Questionnaire-9 is a brief, psychometrically sound, and widely used self-report measure of depression in diverse medical settings. The total score on the PHQ-9 ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)
GPAQ is a validated self-report assessment of physical activity and sedentary behavior. GPAQ does not have a single fixed total score range but a score is calculated in METs-minutes per day. Participants are classified as "active" if they meet or exceed 600 METs-minutes per week.
Number of participants with Bariatric surgery completion
Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review.
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Medical University of South Carolina
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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