Obesity, Smoking Cessation, Bariatric Surgery Patients
Conditions
Brief summary
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.
Detailed description
Smoking prevalence among pre-bariatric surgery patients is estimated to be as high as 40%. In addition to quitting smoking, patients are expected to lose weight before surgery, which is challenging as smoking cessation is associated with weight gain. This study aims to evaluate a multiple health behavior change intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion) for weight loss and smoking cessation for adults seeking bariatric surgery. This pilot randomized control trial will evaluate feasibility and acceptability of the intervention and compare the intervention to a standard of care control group.
Interventions
Participants will be given 50mg/day of Naltrexone for 4 months.
Participants 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).
BEHAVIORALCognitive-Behavioral Therapy
Participants 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.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Participants will be randomly assigned to the active intervention group or the standard of care control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study enrollment to assess Feasibility | 16 weeks | Number of participants enrolled out of participants screened. |
| Mean number treatment sessions attended to assess Feasibility | 16 weeks | Mean number of treatment sessions attended. |
| Retention to assess Feasibility | 16 weeks | Retention will be measured as the percent of participants that attend the post treatment assessment. |
| Treatment credibility to assess Acceptability | Week 4, Week 8, Week 12, Week 16 | 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). |
| Treatment satisfaction to assess Acceptability | Week 16 | Treatment 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 change | Baseline, Week 16, 6-month follow-up | Percent 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 monoxide | Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up | Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration. |
| Smoking cessation, as measured by timeline followback interview | Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up | Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence | Baseline, Week 16, 6-month follow-up | 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 | Baseline, Week 16, 6-month follow-up | 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) | Baseline, Week 16, 6-month follow-up | 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 | 6-month follow-up | Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review. |
Countries
United States
Contacts
CONTACTCaitlin E Smith, PhD
PRINCIPAL_INVESTIGATORCaitlin E Smith, PhD
Yale University
Outcome results
None listed