Naltrexone/Bupropion for Obesity
Trial Summary
What is the purpose of this trial?
The goal of this clinical trial is to understand if genetic variations are associated with the amount of weight loss with diet and while taking an FDA-approved medication for weight loss. The main question\[s\] it aims to answer are: * In Aim One, the investigators propose to rigorously test the hypothesis that presence of the Taq1A A1+ polymorphism is associated with greater weight loss with NB compared with the A1- genotype. * In Aim Two, the investigators will explore other genetic polymorphisms that might influence the efficacy of NB such as the fat mass and obesity-associated (FTO) gene which modulates DRD2 signaling, as carriers of risk alleles in both the FTO and ANKK1 gene demonstrate altered responses to reward-learning tasks associated with negative outcomes. Participants will be in the study for 40 weeks, which consists of two phases: 1. From baseline to week 12, participants will receive individual nutritional counseling on a calorie restricted diet. This phase includes in-person visits, blood tests, an EKG, vital signs, questionnaires, body weight, and nutritional visits. 2. From week 12 to week 40, participants will continue to receive dietary counseling and will receive treatment with naltrexone/bupropion for 28 weeks. This phase includes in-person and phone visits, blood tests, vital signs, questionnaires, body weight, and nutritional visits.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants using dopamine agonists, opioid analgesics, antipsychotics, antidepressants, neuroleptics, naltrexone, diabetes medications, and MAO inhibitors within 14 days prior to screening. It also excludes those using weight loss medication within the prior six months.
What evidence supports the effectiveness of the drug naltrexone/bupropion for obesity?
Research shows that naltrexone/bupropion can lead to significant weight loss and improved quality of life in patients with genetic obesity, as seen in a case where a patient lost 48.9 kg over 17 months. Additionally, a study found that individuals with a specific genetic variant experienced greater weight loss with this drug, suggesting it may be more effective for certain people.12345
Is Naltrexone/Bupropion safe for humans?
How does the drug naltrexone/bupropion work for obesity?
Naltrexone/bupropion is unique because it combines two drugs that work on the brain to help control appetite and cravings, which can lead to significant weight loss. This combination is particularly effective for people with certain genetic traits, like the Taq1A variant, and has shown success where other treatments have failed.12389
Research Team
Judith Korner, MD,PhD
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for men and women aged 18-65 with obesity, defined as a BMI of 30-50, or overweight individuals (BMI 27-29.99) with certain weight-related health issues like controlled high blood pressure, cholesterol problems, sleep apnea, or joint arthritis.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Nutritional Counseling
Participants receive individual nutritional counseling on a calorie restricted diet, including in-person visits, blood tests, an EKG, vital signs, questionnaires, body weight, and nutritional visits
Treatment with Naltrexone/Bupropion
Participants continue dietary counseling and receive treatment with naltrexone/bupropion, including in-person and phone visits, blood tests, vital signs, questionnaires, body weight, and nutritional visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Genetics and Response to Naltrexone/Bupropion (Other)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator