Trial Summary
What is the purpose of this trial?This trial tests a special program and two medications to help people lose weight after weight-loss surgery. It targets patients who still struggle with obesity despite having surgery. The program helps change daily habits, while the medications reduce hunger and cravings.
Is Behavioral Weight Loss a promising treatment for obesity after bariatric surgery?Yes, Behavioral Weight Loss is a promising treatment for obesity after bariatric surgery. It helps manage weight regain, which is common after surgery, by providing strategies for long-term weight management and improving weight loss outcomes.56789
What safety data exists for obesity treatments after bariatric surgery?The research does not directly address safety data for the specific treatments mentioned, such as Behavioral Weight Loss Therapy or the Naltrexone and Bupropion Combination. However, it discusses the effectiveness and outcomes of cognitive behavioral therapy (CBT) and other behavioral interventions in managing weight post-bariatric surgery. These studies highlight the need for additional strategies to improve weight loss maintenance and address weight regain, but they do not provide specific safety data for the treatments listed.24589
What data supports the idea that Pharmacological and Behavioral Treatment for Obesity After Bariatric Surgery is an effective treatment?The available research shows that behavioral treatments, like cognitive behavioral therapy and support groups, can help people lose weight after bariatric surgery. These treatments are especially helpful for those who might start gaining weight again after surgery. Studies have found that these approaches can lead to better weight loss results compared to not using them. This suggests that combining these treatments with surgery can be more effective than surgery alone.12358
Do I have to stop taking my current medications for this trial?The trial requires you to stop taking medications that are contraindications to NB medication, such as MAOIs and opiates, and any other medications for weight loss. The protocol does not specify a washout period.
Eligibility Criteria
This trial is for adults with obesity who've had bariatric surgery but haven't achieved desired weight loss. Participants must have a BMI between 27-50, be in good health, and willing to follow the study plan for up to 18 months. Women must use effective contraception; men should ensure contraception with partners.Inclusion Criteria
I have had weight loss surgery, either gastric bypass or sleeve gastrectomy.
I haven't lost enough weight after my bariatric surgery.
My BMI is between 30 and 50, or it's above 27 with a health condition.
I am a man who can father children and will use contraception.
Exclusion Criteria
I am currently taking medication to lose weight.
I have high blood pressure or a fast heart rate that hasn't been treated.
I have a history of heart or blood vessel diseases, including stroke.
I have poor eye health.
My high blood pressure is not under control.
My diabetes is not currently under control.
I have gallbladder disease.
I am not on medications like MAOIs or opiates that would interfere with the trial drug.
I have a history of severe kidney, liver, nerve, lung diseases, or other unstable conditions.
My thyroid is underactive and not yet treated, confirmed by two tests.
Treatment Details
The study tests if combining behavioral weight loss strategies with a medication (Naltrexone and Bupropion) is more effective than either approach alone or a placebo in improving post-surgery weight loss, cardiovascular health, and mental well-being.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: NB medicationExperimental Treatment1 Intervention
Participants randomly assigned to this arm will receive 6 months of NB medication taken daily in pill form.
Group II: BWL + PlaceboExperimental Treatment2 Interventions
Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Group III: BWL + NB medicationExperimental Treatment2 Interventions
Participants randomly assigned to this arm will receive 6 months of Behavioral Weight Loss (BWL) counseling and NB medication. The naltrexone and bupropion will be taken daily in pill form.
Group IV: PlaceboPlacebo Group1 Intervention
Participants randomly assigned to this arm will receive 6 months 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 School of MedicineNew 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
Optimizing long-term weight control after bariatric surgery: a pilot study. [2021]Although bariatric surgery is associated with significant overall weight loss, many patients experience suboptimal outcomes. Our objective was to document the preliminary efficacy of a behavioral intervention for bariatric surgery patients with relatively poor long-term weight loss and to explore the factors related to outcome at an academic medical center in the United States.
Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials. [2021]Bariatric surgery is currently considered the most effective treatment of severe obesity, but considerable individual variations in weight loss results have been reported. We therefore conducted a systematic review and meta-analysis of studies investigating the effect of psychotherapeutic interventions and support groups on weight loss following bariatric surgery. A literature search was conducted in the databases PubMed and PsycINFO, identifying nine eligible studies reporting results of the effect of psychotherapeutic interventions and support groups on weight loss following bariatric surgery. The results revealed a statistically significant overall effect of both psychotherapeutic interventions and support groups on weight loss (pooled effect size correlation (ESr) = 0.18; p
Outcomes on quality of life, weight loss, and comorbidities after Roux-en-Y gastric bypass. [2019]Bariatric surgery has become the most effective method for producing weight loss in obese patients. The evaluation of improvement of comorbidities and changes in the quality of life are important outcome factors; however, it is necessary to investigate whether they persist over the long term.
Does cognitive behavioral therapy strengthen the effect of bariatric surgery for obesity? Design and methods of a randomized and controlled study. [2018](Extreme) obesity is a chronic harmful condition with high risk of medical comorbidities and negative social and emotional consequences. Bariatric surgery is an effective intervention for obesity, but approximately 20 to 30% of the patients experience adverse outcomes after surgery and there is a need for augmentation of current treatment strategies. This study examines the added value of pre-operative cognitive behavioral therapy (CBT) focused on modification of thoughts and behaviors in terms of eating behavior and physical exercise as well as preparation for surgery and postoperative life style. We hypothesize that pre-operative CBT will result in better weight loss maintenance, reduction of maladaptive eating behavior and better adherence to postoperative lifestyle on the long term as compared to bariatric surgery alone.
Cognitive behavioral therapy and predictors of weight loss in bariatric surgery patients. [2018]Bariatric surgery is the most effective treatment for morbid obesity. However, 20-30% of patients undergoing bariatric surgery experience premature weight stabilization or weight regain postoperatively. We report on the recent literature of predictors of weight loss and the efficacy of cognitive behavioral therapy (CBT) in bariatric patients.
Long-term pharmacotherapy of obesity in patients that have undergone bariatric surgery: pharmacological prevention and management of body weight regain. [2019]The obesity epidemic continues to grow. Bariatric surgery is part of the arsenal to treat the disease. Surgery results in an effective option for patients with severe obesity but also when obesity is associated with significant comorbidities. Weight regain is frequent after bariatric surgery. Consequently, the addition of anti-obesity drugs to prevent and manage weight regain are commonly recommended even when the quality of the evidence supporting this recommendation is relatively weak. cfsda65
Review of Advances in Anti-obesity Pharmacotherapy: Implications for a Multimodal Treatment Approach with Metabolic Surgery. [2021]There is a growing need for treatments for patients who would benefit from further weight loss following bariatric surgery or weight loss maintenance/long-term disease remission. Currently, therapeutic options are limited. Although largely dismissed previously, advances in weight loss pharmacotherapy now offer the possibility of achieving clinically significant weight loss. Historical comparisons drawn between the effects of medications vs surgery are generally inaccurate as novel classes of anti-obesity pharmacotherapy have since been developed and moreover, reflect an outdated approach in comparing medicine with surgery. Herein, we provide an overview of the most recently developed anti-obesity medications which may not only present a potentially innovative approach to medical treatment of obesity but may also inspire renewed enthusiasm for investigating what can be achieved through multimodal care.
Behavioral Interventions After Bariatric Surgery. [2022]Bariatric surgery is the most effective and durable treatment for severe obesity. Postoperative behavioral weight management approaches are available for optimizing weight change for both short- and long-term outcomes.
Management of Weight Regain Following Bariatric Surgery: Behavioral Intervention and Pharmacotherapy. [2022]Bariatric surgery is the most effective intervention currently available for significant and durable weight loss, but weight regain after surgery is not uncommon. This paper focuses on updates in behavioral interventions and pharmacotherapy to combat weight regain after bariatric surgery.