Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:48 PM
Study NCT ID:
NCT07398404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009271', 'term': 'Naltrexone'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to the active intervention group or the standard of care control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study enrollment to assess Feasibility', 'timeFrame': '16 weeks', 'description': 'Number of participants enrolled out of participants screened.'}, {'measure': 'Mean number treatment sessions attended to assess Feasibility', 'timeFrame': '16 weeks', 'description': 'Mean number of treatment sessions attended.'}, {'measure': 'Retention to assess Feasibility', 'timeFrame': '16 weeks', 'description': 'Retention will be measured as the percent of participants that attend the post treatment assessment.'}, {'measure': 'Treatment credibility to assess Acceptability', 'timeFrame': 'Week 4, Week 8, Week 12, Week 16', 'description': '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).'}, {'measure': 'Treatment satisfaction to assess Acceptability', 'timeFrame': 'Week 16', 'description': '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).'}, {'measure': 'Percent weight change', 'timeFrame': 'Baseline, Week 16, 6-month follow-up', 'description': 'Percent weight change will be calculated from baseline to post-treatment, and post-treatment to 6-month follow-up.'}, {'measure': 'Smoking cessation, as measured by exhaled carbon monoxide', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up', 'description': 'Smoking cessation will be evaluated biochemically, through mean exhaled carbon monoxide concentration.'}, {'measure': 'Smoking cessation, as measured by timeline followback interview', 'timeFrame': 'Baseline, Week 4, Week 8, Week 12, Week 16, 6-month follow-up', 'description': 'Smoking cessation will be evaluated behaviorally, through point prevalence abstinence data obtained by timeline followback interviews.'}], 'secondaryOutcomes': [{'measure': 'Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence', 'timeFrame': 'Baseline, Week 16, 6-month follow-up', 'description': '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.'}, {'measure': 'Depressive symptomatology, as measured by the Patient Health Questionnaire-9', 'timeFrame': 'Baseline, Week 16, 6-month follow-up', 'description': '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.'}, {'measure': 'Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ)', 'timeFrame': 'Baseline, Week 16, 6-month follow-up', 'description': '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.'}, {'measure': 'Number of participants with Bariatric surgery completion', 'timeFrame': '6-month follow-up', 'description': 'Bariatric surgery completion will be assessed at 6-month follow-up, through medical record review.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Smoking Cessation', 'Bariatric Surgery Patients']}, 'referencesModule': {'references': [{'pmid': '32524412', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18-65 years old.\n* Be actively considering bariatric surgery.\n* Smoke at least 5 cigarettes daily for the past 3 months.\n* Have a BMI ≥ 30.0 kg/m2.\n* Not currently taking medications that interact with Naltrexone or Bupropion (e.g., opiates, benzodiazepines).\n* 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).\n* Physically well enough to participate in the intervention (e.g., able to walk independently).\n* Speak/read/write in English.\n* Not currently pregnant or breastfeeding or have plans to become pregnant or breastfeed during the study.\n* No active suicidal or homicidal ideation.\n\nExclusion Criteria:\n\n* Has an acute medical or psychiatric disorder that would make participation difficult or unsafe.\n* Has suicidal or homicidal ideation that requires immediate attention.\n* 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).\n* 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.\n* Has stage 2 hypertension (blood pressure greater than 160/100 or heart rate over 100 beats/minute).\n* Has elevated bilirubin test or any other liver function test value \\> 5 times the upper limit of normal laboratory criteria.\n* Has a platelet count \\< 100x10 3/uL.\n* Has a history of anorexia nervosa or history of bulimia nervosa.\n* Is currently taking a medication that is contraindicated to Naltrexone or Bupropion (e.g., MAOIs, opiates).\n* Has a history of allergy or sensitivity to Naltrexone or Bupropion.\n* Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression).\n* Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.\n* Has current uncontrolled Type I or Type 2 diabetes mellitus.\n* Has a history of severe renal, hepatic, neurological, chronic pulmonary, or gallbladder disease, or any other unstable medical disorder, including cancer.\n* Has angle closure glaucoma.\n* Has taken an investigational drug in another study within 30 days of study consent.\n* Has been prescribed and taken Naltrexone or Bupropion within 30 days of study consent.\n* Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder treatment.\n* 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.\n* Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study.\n* Requires treatment with opioid-containing medications during the study period.\n* Has a surgery planned other than bariatric surgery.\n* 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.\n* Is currently pregnant, breastfeeding, or plans to become pregnant during the study, or is not using a reliable form of birth control.'}, 'identificationModule': {'nctId': 'NCT07398404', 'briefTitle': 'A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Multiple Health Behavior Change Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients', 'orgStudyIdInfo': {'id': '2000041823'}, 'secondaryIdInfos': [{'id': '1K23DA064898-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23DA064898-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MHBC Intervention Group', 'description': 'Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).', 'interventionNames': ['Drug: Naltrexone hydrochloride', 'Drug: Bupropion Hydrochloride Extended-release', 'Behavioral: Cognitive-Behavioral Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.'}], 'interventions': [{'name': 'Naltrexone hydrochloride', 'type': 'DRUG', 'description': 'Participants will be given 50mg/day of Naltrexone for 4 months.', 'armGroupLabels': ['MHBC Intervention Group']}, {'name': 'Bupropion Hydrochloride Extended-release', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['MHBC Intervention Group']}, {'name': 'Cognitive-Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['MHBC Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'contacts': [{'name': 'Caitlin E Smith, PhD', 'role': 'CONTACT', 'email': 'caitlin.smith@yale.edu', 'phone': '203-785-7210'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Caitlin E Smith, PhD', 'role': 'CONTACT', 'email': 'caitlin.smith@yale.edu', 'phone': '203-785-7210'}], 'overallOfficials': [{'name': 'Caitlin E Smith, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}