A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorYale University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Naltrexone hydrochloride
  • Bupropion Hydrochloride Extended-release
  • Cognitive-Behavioral Therapy

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator