~54 spots leftby Jan 2027

Pharmacological and Behavioral Treatment for Obesity After Bariatric Surgery

VI
Overseen byValentina Ivezaj, Ph.D.
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.12345

Is 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.12367

How 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.12689

Research Team

VI

Valentina Ivezaj, Ph.D.

Principal Investigator

Yale University

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

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
See 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
See 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

Treatment Details

Interventions

  • Behavioral Weight Loss (Behavioral Intervention)
  • Naltrexone and Bupropion Combination (Combination Drug)
  • Placebo (Other)
Trial OverviewThe 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.
Participant Groups
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.

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+

Findings from Research

Bariatric surgery is recognized as the most effective long-term treatment for severe obesity, and combining it with behavioral weight management strategies can enhance weight loss outcomes.
Recent studies have explored various settings and techniques, like cognitive behavioral therapy and telemedicine, for post-surgery support, but challenges such as funding and participant dropout have limited their widespread application.
Behavioral Interventions After Bariatric Surgery.Tewksbury, C., Isom, KA.[2022]
Cognitive Behavioral Therapy (CBT) has been shown to effectively reduce disordered eating behaviors and depressive symptoms in bariatric patients, which are linked to less optimal weight loss outcomes after surgery.
Innovative CBT delivery methods, such as telephone and internet-based programs, may provide accessible and cost-effective support for bariatric patients, potentially improving their long-term weight loss success.
Cognitive behavioral therapy and predictors of weight loss in bariatric surgery patients.Paul, L., van der Heiden, C., Hoek, HW.[2018]
Psychotherapeutic interventions and support groups significantly enhance weight loss outcomes after bariatric surgery, with a pooled effect size correlation of 0.18 based on a systematic review of nine studies.
There was no significant difference in effectiveness between psychotherapeutic interventions and support groups, suggesting that both approaches can be beneficial for patients undergoing bariatric surgery.
Do postoperative psychotherapeutic interventions and support groups influence weight loss following bariatric surgery? A systematic review and meta-analysis of randomized and nonrandomized trials.Beck, NN., Johannsen, M., Støving, RK., et al.[2021]

References

Behavioral Interventions After Bariatric Surgery. [2022]
Cognitive behavioral therapy and predictors of weight loss in bariatric surgery patients. [2018]
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]
Optimizing long-term weight control after bariatric surgery: a pilot study. [2021]
Outcomes on quality of life, weight loss, and comorbidities after Roux-en-Y gastric bypass. [2019]
Management of Weight Regain Following Bariatric Surgery: Behavioral Intervention and Pharmacotherapy. [2022]
Does cognitive behavioral therapy strengthen the effect of bariatric surgery for obesity? Design and methods of a randomized and controlled study. [2018]
Review of Advances in Anti-obesity Pharmacotherapy: Implications for a Multimodal Treatment Approach with Metabolic Surgery. [2021]
Long-term pharmacotherapy of obesity in patients that have undergone bariatric surgery: pharmacological prevention and management of body weight regain. [2019]