NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

Not Yet RecruitingPhase 1

Sponsor: Medical University of South Carolina

Conditions: Obesity, Smoking Cessation, Bariatric Surgery Patients

Interventions: Naltrexone Hydrochloride, Bupropion HCl Extended Release, Cognitive-Behavioral Therapy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Locations (1)

Charleston, South Carolina, United States