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

Официальное название

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

Обзор

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.

Подробное описание

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. Pre-bariatric surgery patients would significantly benefit from a tailored multiple health behavior change intervention targeting weight loss and smoking cessation concurrently, yet no such interventions have been examined within this patient population.

This study aims to develop and pilot 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 will evaluate the feasibility and acceptability of the intervention, as well as use a mixed methods approach for intervention refinement. Weight loss and smoking cessation will be assessed post-treatment. This study will provide important preliminary data needed to develop an effective intervention that will address weight loss and smoking cessation concurrently, which is needed to improve bariatric surgery utilization and reduce risk for smoking relapse post-surgery for this high-risk patient population.

Вмешательства

• Препарат Naltrexone Hydrochloride
  Participants will be given 50mg/day of Naltrexone for 4 months.
• Препарат Bupropion HCl 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).
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

• Nicotine dependence, as measured by the Fagerstrom Test for Nicotine Dependence [Срок оценки: Baseline and Week 16]
• Depressive symptomatology, as measured by the Patient Health Questionnaire-9 [Срок оценки: Baseline and Week 16]
• Physical activity, as measured by the Global Physical Activity Questionnaire (GPAQ) [Срок оценки: Baseline and Week 16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Публикации

• 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

Идентификаторы

NCT: NCT07224087 · 2000041069

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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