Opening soonPhase 1, Phase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Smoking Cessation, Bariatric Surgery Patients
Full registry criteria
Inclusion Criteria: * 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. * Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines). * No history of medical conditions that are contraindicated with Naltrexone or - Bupropion (e.g., seizure disorders, uncontrolled hypertension, cardiac issues including history of heart attacks, heart disease, or stroke, history of anorexia or bulimia nervosa). * Physically well enough to participate in the intervention (e.g., able to walk independently). * Speak/read/write in English. * Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study. * No active suicidal or homicidal ideation. Exclusion Criteria: * 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. * Has stage 2 hypertension (blood pressure greater than 160/100 or heart rate over 100 beats/minute). * Has elevated bilirubin test or any other liver function test value \> 5 times the upper limit of normal laboratory criteria. * Has a platelet count \< 100x10 3/uL. * Has a history of anorexia nervosa or history of bulimia nervosa. * Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates). * Has a history of allergy or sensitivity to Naltrexone or Bupropion. * Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression). * Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke. * Has current uncontrolled Type I or Type 2 diabetes mellitus. * Has a history of severe renal, hepatic, neurological, chronic pulmonary, or gallbladder disease, or any other unstable medical disorder, including cancer. * Has angle closure glaucoma. * Has taken an investigational drug in another study within 30 days of study consent. * Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent. * Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment. * Is receiving ongoing treatment with tricyclic antidepressants, xanthines, systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous stimulants, or any medication that could interact adversely with the study medications. * Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study. * Requires treatment with opioid-containing medications during the study period. * Has a surgery planned other than bariatric surgery. * Is currently in jail, prison, or any inpatient overnight facility as required by a court of law or have pending legal action or other legal situation that could prevent participation. * Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.
Primary outcomes
Study enrollment to assess Feasibility16 weeksNumber of participants enrolled out of participants screened.
Mean number treatment sessions attended to assess Feasibility16 weeksMean number of treatment sessions attended.
Retention to assess Feasibility16 weeksRetention will be measured as the percent of participants that attend the post treatment assessment.
Treatment credibility to assess AcceptabilityWeek 4, Week 8, Week 12, Week 16Treatment 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).
Treatment satisfaction to assess AcceptabilityWeek 16Treatment satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is satisfactory (0-100%, with higher scores being indicative of higher treatment satisfaction).
Percent weight changeBaseline, Week 16, 6-month follow-upPercent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.
Smoking cessation, as measured by exhaled carbon monoxideBaseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-upSmoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.
Smoking cessation, as measured by timeline followback interviewBaseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-upSmoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.
