Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYale University
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Naltrexone Hydrochloride
- Bupropion HCl Extended Release
- Cognitive-Behavioral Therapy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Yale University
Lead sponsor
American Society for Metabolic and Bariatric Surgery
Collaborator
Source ClinicalTrials.gov