A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Official title

A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Overview

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

• Drug Naltrexone hydrochloride
  Participants will be given 50mg/day of Naltrexone for 4 months.
• Drug Bupropion Hydrochloride Extended-release
  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).
• Behavioral Cognitive-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.

Primary outcome measures

• Study enrollment to assess Feasibility [Time frame: 16 weeks]
• Mean number treatment sessions attended to assess Feasibility [Time frame: 16 weeks]
• Retention to assess Feasibility [Time frame: 16 weeks]
• Treatment credibility to assess Acceptability [Time frame: Week 4, Week 8, Week 12, Week 16]
• Treatment satisfaction to assess Acceptability [Time frame: Week 16]
• Percent weight change [Time frame: Baseline, Week 16, 6-month follow-up]
• Smoking cessation, as measured by exhaled carbon monoxide [Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up]
• Smoking cessation, as measured by timeline followback interview [Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up]

Secondary outcome measures (4)

• Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence [Time frame: Baseline, Week 16, 6-month follow-up]
• Depressive symptomatology, as measured by the Patient Health Questionnaire-9 [Time frame: Baseline, Week 16, 6-month follow-up]
• Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ) [Time frame: Baseline, Week 16, 6-month follow-up]
• Number of participants with Bariatric surgery completion [Time frame: 6-month follow-up]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Medical University of South Carolina — Charleston

Publications

• Chow A, Neville A, Kolozsvari N. Smoking in bariatric surgery: a systematic review. Surg Endosc. 2021 Jun;35(6):3047-3066. doi: 10.1007/s00464-020-07669-3. Epub 2020 Jun 10. PMID 32524412

Identifiers

NCT: NCT07398404 · 2000041823 · 1K23DA064898-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗