NB Medication for Weight Management After Bariatric Surgery

Recruiting in Palo Alto (17 mi)

Overseen byValentina Ivezaj, Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Yale University

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Research Team

Valentina Ivezaj, Ph.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults aged 18-70 who've had bariatric surgery, are experiencing loss-of-control eating post-surgery, and responded to initial treatment. Participants must be healthy with controlled medical conditions and not using drugs or heavy alcohol. Pregnant women, those with certain heart diseases, uncontrolled diabetes or hypertension, seizure risks, severe psychiatric disorders, or allergies to the study medications cannot join.

Inclusion Criteria

I started losing control over eating 6 months post-bariatric surgery and responded well to a 4-month treatment.

Read, comprehend, and write English at a sufficient level to complete study-related materials.

Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).

See 5 more

Exclusion Criteria

You have a history of eating disorders such as anorexia or bulimia.

You have a mental health condition that requires hospitalization or intensive treatment, such as bipolar disorder, psychosis, or severe depression.

I have gallbladder disease.

See 15 more

Treatment Details

Interventions

Naltrexone and Bupropion (NB) medication (Other)
Placebo (Other)

Trial OverviewThe study tests if Naltrexone/Bupropion (NB) medication helps maintain weight loss and control overeating after bariatric surgery better than a placebo. It's for those who initially responded well to treatments and will compare long-term outcomes between the NB medication group and the placebo group over a period of up to 15 months.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Naltrexone+Bupropion MedicationExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention