Naltrexone + Bupropion + Cognitive Behavioral Therapy for Obesity and Smoking Cessation

This trial examines how well a combination of two medications, Naltrexone (used to manage alcohol or opioid dependence) and Bupropion (an antidepressant also used for smoking cessation), along with therapy, can aid in weight loss and smoking cessation. It targets individuals considering bariatric surgery who have smoked at least five cigarettes daily for the past three months. Eligible participants should have a BMI of 30 or higher and not be on medications that interact with Naltrexone or Bupropion. Participants will be divided into two groups: one will receive the new treatment, while the other will continue with standard care. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

You may need to stop taking certain medications that interact with Naltrexone or Bupropion, such as opiates, benzodiazepines, or MAOIs. It's important to discuss your current medications with the study team to see if any changes are needed.

Research has shown that using naltrexone and bupropion together can aid in weight loss and smoking cessation. Studies involving individuals who are overweight or obese and smoke have found that this combination, along with counseling, can reduce smoking.

However, while naltrexone and bupropion are approved for use, limited information exists about their cardiovascular safety when used together. Although generally safe, specific data on their effects on heart health is lacking.

Researchers are excited about the Multiple Health Behavior Change (MHBC) Intervention because it combines medications and therapy in a new way. Unlike standard treatments that typically focus on either obesity or smoking cessation separately, this approach uses Naltrexone and Bupropion together with Cognitive Behavioral Therapy to tackle both issues at once. Bupropion helps reduce cravings and withdrawal symptoms, while Naltrexone works on the brain's reward system to decrease the desire to overeat or smoke. By addressing both obesity and smoking simultaneously, this treatment has the potential to achieve better health outcomes than current options.

Research has shown that using Naltrexone and Bupropion together can aid in weight loss and smoking cessation. In past studies, this combination helped individuals smoke less and manage their weight if they were overweight or obese smokers. Some research also suggests that Naltrexone can prevent weight gain after quitting smoking. In this trial, participants in the MHBC Intervention Group will receive this medication combination along with behavioral counseling. When combined with behavioral counseling, such as therapy or coaching, these medications have shown promising results for those trying to quit smoking and lose weight. Overall, this combination of drugs, along with support, might help individuals control both their weight and smoking habits.¹²³⁶⁷