160 Participants Needed

Medication + Behavioral Therapy for Post-Bariatric Surgery Weight Control

VI
Overseen ByValentina Ivezaj, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Yale University
Must be taking: Naltrexone, Bupropion
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial will test different treatments for people who have trouble controlling their eating and weight after weight-loss surgery. The treatments include behavior therapy to change eating habits and a combination of two medications to reduce cravings. The goal is to find out which approach works best for these patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that are a contraindication to the study medication, such as MAOIs or opiates, and any other medications for weight loss. If you are on these medications, you may need to stop them to participate.

Is the combination of naltrexone and bupropion safe for weight management in humans?

The combination of naltrexone and bupropion, used for weight management, has been generally well tolerated in clinical trials, with nausea being the most common side effect. These trials showed that it is a safe option for managing weight in obese adults or those with weight-related health issues.12345

How does the drug combination of naltrexone and bupropion help with weight control after bariatric surgery?

The combination of naltrexone and bupropion is unique because it targets the brain's reward system to help control eating behavior, making it more effective for weight loss when combined with lifestyle changes than either drug alone. This approach is particularly useful for managing weight regain after bariatric surgery, offering a novel option compared to traditional weight loss medications.16789

What data supports the effectiveness of the drug Naltrexone/Bupropion for weight control after bariatric surgery?

Research shows that the combination of Naltrexone and Bupropion is effective for weight loss in obese adults, especially when combined with lifestyle changes and calorie reduction. Studies indicate that this combination can lead to significant weight loss, more than using each drug alone.135910

Are You a Good Fit for This Trial?

Adults aged 18-70 who've had bariatric surgery (gastric bypass or sleeve gastrectomy) about six months ago, with a BMI of 30-50 (or ≥27 if they have certain health issues), experiencing weekly loss-of-control eating. They must be generally healthy, not on weight loss or contraindicated meds, and able to commit to up to 19 months in the study.

Inclusion Criteria

Provide a signed and dated written informed consent prior to study participation.
Be available for participation in the study for up to 19 months (7-month treatment plus 12-month follow up).
I have had weight loss surgery.
See 9 more

Exclusion Criteria

Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
My blood pressure or heart rate is higher than normal and untreated.
I am currently receiving treatment for an eating disorder or to lose weight.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 16 weeks of behavioral weight loss counseling and/or naltrexone/bupropion medication or placebo

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Behavioral Weight Loss
  • Naltrexone and Bupropion medication
  • Placebo
Trial Overview The trial is testing how well behavioral weight loss strategies work compared to or combined with Naltrexone/Bupropion medication for controlling eating and managing weight after bariatric surgery. Participants will either receive the drug combo, placebo, or just behavioral therapy.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Placebo Group
Group I: NB medicationExperimental Treatment1 Intervention
Group II: Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medicationExperimental Treatment2 Interventions
Group III: BWL + PlaceboExperimental Treatment2 Interventions
Group IV: PlaceboPlacebo Group1 Intervention

Behavioral Weight Loss is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Behavioral Weight Loss Therapy for:
🇪🇺
Approved in European Union as Intensive Behavioral Therapy for Obesity for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

Naltrexone/bupropion ER, marketed as Contrave, is a newly approved medication specifically designed for chronic weight management in obese adults.
This combination therapy targets both appetite suppression and energy expenditure, offering a new option for individuals struggling with obesity.
Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults.Sherman, MM., Ungureanu, S., Rey, JA.[2020]
Naltrexone/bupropion, an investigational weight loss medication, resulted in a significant mean weight loss of 4.7% after one year in obese patients, with 26-33% of participants achieving at least 5% weight loss compared to placebo.
In addition to weight loss, naltrexone/bupropion improved various health markers, including waist circumference and triglyceride levels, and reduced hemoglobin A1c by approximately 0.5% in patients with diabetes, although it had some common side effects like nausea and dizziness.
Naltrexone/bupropion: an investigational combination for weight loss and maintenance.Makowski, CT., Gwinn, KM., Hurren, KM.[2022]
A systematic review of 14 studies, including 10 randomized controlled trials, found that naltrexone/bupropion is effective for weight loss in obese patients, with many achieving at least 5% or 10% weight loss as a primary outcome.
The treatment was generally well tolerated, with few reported side effects, suggesting it is a safe option for weight management, especially when combined with mental health support.
Safety and efficacy of naltrexone for weight loss in adult patients - a systematic review.Kulak-Bejda, A., Bejda, G., Waszkiewicz, N.[2022]

Citations

Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. [2020]
Naltrexone/bupropion: an investigational combination for weight loss and maintenance. [2022]
Safety and efficacy of naltrexone for weight loss in adult patients - a systematic review. [2022]
Naltrexone HCI/bupropion HCI for chronic weight management in obese adults: patient selection and perspectives. [2022]
The efficacy and safety of the naltrexone/bupropion combination for the treatment of obesity: an update. [2019]
Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes. [2016]
Naltrexone ER/Bupropion ER: A Review in Obesity Management. [2018]
Combination therapy with naltrexone and bupropion for obesity. [2013]
9.Czech Republicpubmed.ncbi.nlm.nih.gov
Antiobesity drugs before and after bariatric surgery - how to make the best use of them. [2022]
The effectiveness and safety of pharmaceuticals to manage excess weight post-bariatric surgery: a systematic literature review. [2020]
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