Pharmacological and Behavioral Treatment for Obesity After Bariatric Surgery
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 not be taking: MAOI, Opiates, Weight loss meds
Disqualifiers: Seizures, Bulimia, Bipolar, Hypertension, others
Prior Safety Data
Approved in 2 Jurisdictions
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that are a contraindication to NB medication (like MAOIs or opiates) or if you are using other weight loss medications.
What data supports the effectiveness of this treatment for obesity after bariatric surgery?
Research shows that behavioral interventions, like therapy and support groups, can help improve weight loss after bariatric surgery. These approaches are effective in managing weight changes and improving long-term outcomes for patients.
12345Is the combination of behavioral therapy and pharmacological treatment safe for humans after bariatric surgery?
The research does not provide specific safety data for the combination of behavioral therapy and pharmacological treatment after bariatric surgery. However, these interventions are generally used to manage weight and improve outcomes, suggesting they are considered safe for this purpose.
12367How is Behavioral Weight Loss Therapy different from other treatments for weight regain after bariatric surgery?
Behavioral Weight Loss Therapy is unique because it focuses on changing lifestyle habits and behaviors to manage weight regain after bariatric surgery, rather than relying solely on medication or surgery. This approach can help patients achieve long-term weight management by addressing the underlying behaviors that contribute to weight gain.
12689Eligibility 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
Stated willingness to comply with all study procedures and availability for the duration of the study (up to 18 months: 6-month treatment plus 12-month follow up)
Must be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies)
For females of reproductive potential: must use highly effective contraception and agree to use such a method during study participation
+7 more
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.
Has a history of allergy or sensitivity to bupropion or naltrexone
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 6 months of either NB medication, Behavioral Weight Loss counseling, or a combination, with daily pill intake
6 months
Follow-up
Participants are monitored for changes in depressive symptoms, cholesterol, HbA1C, BMI, and other health metrics
6 months
Participant Groups
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
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.
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.
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
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.
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.
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.
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.
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.
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