Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

NCT07224087 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2000041069
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to develop and pilot a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery.

Conditions

Obesity; Smoking Cessation; Bariatric Surgery Patients

Outcome Measures

Primary Outcomes (7)

• Study enrollment to assess Feasibility

  Number of participants enrolled out of participants screened

  16 weeks

• Mean number treatment sessions attended to assess Feasibility

  Mean number of treatment sessions attended

  16 weeks

• Retention to assess Feasibility

  Retention will be measured as the percent of participants that attend the post treatment assessment

  16 weeks

• Treatment credibility and satisfaction to assess Acceptability

  Treatment credibility and satisfaction will be assessed via self-report at post-treatment. Acceptability measured as the percent of participants that agree the intervention is acceptable.

  16 weeks

• Percent weight change

  Percent weight change will be calculated from baseline to post-treatment.

  Baseline and Week 16

• Smoking cessation, as measured by exhaled carbon monoxide

  Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.

  Baseline, Week 4, Week 8, Week 12, Week 16

• Smoking cessation, as measured by timeline followback interview

  Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.

  Baseline, Week 4, Week 8, Week 12, Week 16

Secondary Outcomes (3)

• Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence

  Baseline and Week 16

• Depressive symptomatology, as measured by the Patient Health Questionnaire-9

  Baseline and Week 16

• Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)

  Baseline and Week 16

Study Arms (1)

Intervention

EXPERIMENTAL

Participants will receive the multiple health behavior change intervention with combined medication (Naltrexone 50mg/day; Bupropion Extended Release 300mg/day) and behavior therapy (Cognitive-Behavioral Therapy) for 4 months.

Drug: Naltrexone Hydrochloride; Drug: Bupropion HCl Extended Release; Behavioral: Cognitive-Behavioral Therapy

Interventions

Naltrexone Hydrochloride DRUG

Participants will be given 50mg/day of Naltrexone for 4 months.

Intervention

Bupropion HCl Extended Release DRUG

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).

Intervention

Cognitive-Behavioral Therapy BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Be 18-65 years old.
• Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study.
• No active suicidal or homicidal ideation.

You may not qualify if:

• 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 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 untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute.
• 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.
• Is breast-feeding or is pregnant or is not using a reliable form of birth control.
• Reports active suicidal or homicidal ideation.

Sponsors & Collaborators

• American Society for Metabolic and Bariatric Surgery: collaborator
• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Obesity; Smoking Cessation

Interventions

Naltrexone; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Caitlin E Smith, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin E Smith, PhD

CONTACT

203-785-7210; caitlin.smith@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the intervention.

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: November 3, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)