Medication + Behavioral Therapy for Post-Bariatric Surgery Weight Control
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Yale University
Must be taking: Naltrexone, Bupropion
Must not be taking: MAOI, Opiates
Disqualifiers: Seizures, Bulimia, Hypertension, Diabetes, others
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
12367How 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.
148910Eligibility Criteria
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 am between 18 and 70 years old.
+11 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.
+15 more
Trial Timeline
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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: NB medicationExperimental Treatment1 Intervention
Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.
Group II: Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medicationExperimental Treatment2 Interventions
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
Group III: BWL + PlaceboExperimental Treatment2 Interventions
Participants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form.
Group IV: PlaceboPlacebo Group1 Intervention
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
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:
- Obesity
- Weight Loss Maintenance
- Type 2 Diabetes Prevention
🇪🇺 Approved in European Union as Intensive Behavioral Therapy for Obesity for:
- Obesity
- Weight Loss Maintenance
- Type 2 Diabetes Prevention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale Department of PsychiatryNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Naltrexone/Bupropion ER (Contrave): Newly Approved Treatment Option for Chronic Weight Management in Obese Adults. [2020]Naltrexone/bupropion ER (Contrave): newly approved treatment option for chronic weight management in obese adults.
Naltrexone/bupropion: an investigational combination for weight loss and maintenance. [2022]Naltrexone/bupropion is an investigational combination for weight loss and maintenance in patients who are obese or have a BMI ≥ 27 kg/m(2) with comorbid diabetes, hypertension or hyperlipidemia. Pooled results from four phase 3 trials reveal placebo-subtracted mean weight loss of 4.7% (range 3.2-5.2%) with naltrexone/bupropion after 1 year (p
Safety and efficacy of naltrexone for weight loss in adult patients - a systematic review. [2022]This is a report of a systematic review of the safety and efficacy of naltrexone or naltrexone/bupropion on weight loss.
Naltrexone HCI/bupropion HCI for chronic weight management in obese adults: patient selection and perspectives. [2022]Naltrexone, an opiate antagonist, and bupropion, a noradrenergic/dopaminergic antidepressant, have many effects on the reward systems of the brain. These medications impact eating behavior, presumably via their impact on food reward. However, only bupropion induces weight loss in obese individuals, while naltrexone does not have any appreciable effect. The combination of 32 mg of naltrexone and 360 mg of bupropion in a sustained-release combination pill form has been recently approved for obesity treatment. Studies have shown that the combination of these two medications is more effective in inducing weight loss, when combined with lifestyle intervention and calorie reduction, than each individual medicine alone. The naltrexone-bupropion combination, when combined with lifestyle intervention and modest calorie reduction, seems to be quite effective for 6-month and 1-year outcomes for clinically significant weight loss (over 5% of total body weight). These medications are not devoid of serious side effects, however, and careful patient selection can reduce dramatic complications and increase positive outcomes. This paper reviews existing weight loss clinical trials with bupropion and the bupropion-naltrexone combination. Additionally, the rationale for the suggested patient selection and clinical strategies for special patient populations are discussed.
The efficacy and safety of the naltrexone/bupropion combination for the treatment of obesity: an update. [2019]The combination of 32 mg naltrexone and 360 mg bupropion prolonged release (NB32) was recently approved by both the food and drug administration (FDA) and the European medicines agency (EMA) as an adjunct to a comprehensive lifestyle intervention to achieve weight loss.
Naltrexone/bupropion for the treatment of obesity and obesity with Type 2 diabetes. [2016]Contrave(®) is a combination of naltrexone hydrochloride extended release and bupropion hydrochloride extended release for the treatment of obesity, and is used with lifestyle modification. Its safety and efficacy were assessed in four randomized, double-blind, placebo-controlled, 56-week Phase III clinical trials in 4536 adult subjects: COR-1, COR-II, COR-BMOD and COR-DM. All four studies demonstrated statistically significant and clinically meaningful weight loss following up to 52 weeks of treatment with naltrexone/bupropion compared with placebo. The average weight loss from baseline across the four studies was approximately 11-22 lbs (5-9 kg). Results show the efficacy of Contrave for weight loss, as well as significant improvements in cardiometabolic markers. This review focuses on the four studies, their outcomes and the mechanism of action of Contrave.
Naltrexone ER/Bupropion ER: A Review in Obesity Management. [2018]Oral naltrexone extended-release/bupropion extended-release (naltrexone ER/bupropion ER; Contrave(®), Mysimba(™)) is available as an adjunct to a reduced-calorie diet and increased physical activity in adults with an initial body mass index (BMI) of ≥ 30 kg/m(2) (i.e. obese) or a BMI of ≥ 27 kg/m(2) (i.e. overweight) in the presence of at least one bodyweight-related comorbidity, such as type 2 diabetes mellitus, hypertension or dyslipidaemia. In 56-week phase III trials in these patient populations, oral naltrexone ER/bupropion ER 32/360 mg/day was significantly more effective than placebo with regard to percentage bodyweight reductions from baseline and the proportion of patients who achieved bodyweight reductions of ≥ 5 and ≥ 10%. Significantly greater improvements in several cardiometabolic risk factors were also observed with naltrexone ER/bupropion ER versus placebo, as well as greater improvements in glycated haemoglobin levels in obese or overweight adults with type 2 diabetes. Naltrexone ER/bupropion ER was generally well tolerated in phase III trials, with nausea being the most common adverse event. Thus, naltrexone ER/bupropion ER 32/360 mg/day as an adjunct to a reduced-calorie diet and increased physical activity, is an effective and well tolerated option for chronic bodyweight management in obese adults or overweight adults with at least one bodyweight-related comorbidity.
Combination therapy with naltrexone and bupropion for obesity. [2013]Although pharmacological treatments for obesity represent only one option in managing obesity, they are a useful tool in an otherwise extremely limited armamentarium. Naltrexone/bupropion combination therapy was developed by using technological advances that have improved our understanding of how the brain regulates body weight.
Antiobesity drugs before and after bariatric surgery - how to make the best use of them. [2022]Obesity as a chronic, serious, and progressive lifelong disease requires an active approach to treatment. Treatment means necessary adjustment of lifestyle with suitable regular physical activity, including pharmacological or bariatric support. Current pharmacological treatment can be an effective helper in the preparation for the surgical treatment of obesity (bariatric and metabolic operations), and in greater adherence of the patient to the necessary regime changes in life and in preoperative weight reduction. With the lapse of time after surgical treatment, in many cases we indicate the start of pharmacological treatment if the weight increases again. We do not yet know the appropriate types of patients and the exact indications for specific therapeutic modalities - a suitable antiobesity drug or type of bariatric surgery. The best long-term results come from a combination of at least two of these options, along with a lifestyle change. Among modern antiobesity drugs, there are naltrexone-bupropion and liraglutide. Orlistat can be mentioned from older ones.
The effectiveness and safety of pharmaceuticals to manage excess weight post-bariatric surgery: a systematic literature review. [2020]Objective: To systematically review the literature on weight management pharmaceutical use in patients who have had bariatric surgery. Methods: Google Scholar, Pubmed, Cochrane, Embase, Web of Science, and Clinical Trials were searched from inception to December 31st, 2018 inclusive. Results: Thirteen studies met inclusion and reported decreases in weight with the use of weight management medications in post-bariatric surgical patients. Five studies examined weight loss outcomes by the type of bariatric surgery procedure, and four of these studies observed less weight loss in patients who had undergone gastric sleeve compared to those who had roux-en-y bypass (n = 3 papers) and adjustable gastric banding (n = 1 paper) with medication use. Four studies compared the effectiveness of medications for weight management and observed slightly greater weight loss with the use of topiramate and phentermine as a monotherapy compared to other weight loss medications. Using a sub-sample of participants, authors observed less weight loss on metformin but not phentermine or topiramate for younger adults. Another post-hoc analysis in the same sample observed greater weight loss for older adults with liraglutide 1.8 mg. Side effects were reported in seven studies and were overall consistent with those previously reported in non-surgical populations. Conclusion: Results of this systematic review suggest pharmacotherapy may be an effective tool as an adjunct to diet and physical activity to support weight loss in post-bariatric surgery patients. However, due to most studies lacking a control or placebo group, more rigorous research is required to determine the efficacy of this intervention.