NCT07398404

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
61mo left

Started Jul 2026

Longer than P75 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

4.5 years

First QC Date

January 28, 2026

Last Update Submit

March 17, 2026

Conditions

ObesitySmoking CessationBariatric Surgery Patients

Outcome Measures

Primary Outcomes (8)

  • 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 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).

    Week 4, Week 8, Week 12, Week 16

  • Treatment satisfaction to assess Acceptability

    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).

    Week 16

  • Percent weight change

    Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.

    Baseline, Week 16, 6-month follow-up

  • 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, 6-month follow-up

  • 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, 6-month follow-up

Secondary Outcomes (4)

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

    Baseline, Week 16, 6-month follow-up

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

    Baseline, Week 16, 6-month follow-up

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

    Baseline, Week 16, 6-month follow-up

  • Number of participants with Bariatric surgery completion

    6-month follow-up

Study Arms (2)

MHBC Intervention Group

EXPERIMENTAL

Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).

Drug: Naltrexone hydrochlorideDrug: Bupropion Hydrochloride Extended-releaseBehavioral: Cognitive-Behavioral Therapy

Control Group

NO INTERVENTION

Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.

Interventions

Cognitive-Behavioral TherapyBEHAVIORAL

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.

MHBC Intervention Group
Naltrexone hydrochlorideDRUG

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

MHBC Intervention Group
Bupropion Hydrochloride Extended-releaseDRUG

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).

MHBC Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

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: 32524412BACKGROUND

MeSH Terms

Conditions

ObesitySmoking Cessation

Interventions

NaltrexoneCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Caitlin E Smith, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin E Smith, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to the active intervention group or the standard of care control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 9, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)