Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)

NCT04599478 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000029057R01DK126637-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.

Conditions

Loss-of-control Eating; Obesity/Overweight

Outcome Measures

Primary Outcomes (2)

• Loss-of-control Eating Frequency

  Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.

  Post-treatment (4 months)

• Body Mass Index

  BMI is calculated using measured height and weight

  Post-treatment (4 months)

Secondary Outcomes (4)

• Loss-of-control Eating Remission

  Post-treatment (4 months)

• Weight loss

  Post-treatment (4 months)

• Eating Disorder Psychopathology

  Post-treatment (4 months)

• Depressive Symptoms

  Post-treatment (4 months)

Study Arms (4)

Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication

EXPERIMENTAL

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.

Drug: Naltrexone and Bupropion medication; Behavioral: Behavioral Weight Loss

BWL + Placebo

EXPERIMENTAL

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.

Behavioral: Behavioral Weight Loss; Other: Placebo

NB medication

EXPERIMENTAL

Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form.

Drug: Naltrexone and Bupropion medication

Placebo

PLACEBO COMPARATOR

Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.

Other: Placebo

Interventions

Naltrexone and Bupropion medication DRUG

NB medication will be taken daily in pill form.

Also known as: Contrave

Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication; NB medication

Behavioral Weight Loss BEHAVIORAL

Behavioral Weight Loss (BWL) counseling includes weekly sessions.

BWL + Placebo; Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication

Placebo OTHER

Placebo will be inactive and taken daily in pill form.

BWL + Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be in the age range ≥18 years of age and ≤70 years of age.
• Have a BMI ≥30 (or BMI ≥27 with a medical comorbidity) and ≤50
• Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
• Approximately six months post-surgery
• Experience regular loss-of-control eating (defined as at least once weekly over the past 28 days)
• Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
• Read, comprehend, and write English at a sufficient level to complete study-related materials.
• 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).

You may not qualify if:

• Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
• Has a history of anorexia nervosa or history of bulimia nervosa.
• Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
• Is currently using other medications for weight loss.
• Has a history of allergy or sensitivity to bupropion or naltrexone.
• Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
• Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute.
• Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
• Has current uncontrolled hypertension.
• Has current uncontrolled Type I or Type II diabetes mellitus.
• Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.
• Has gallbladder disease.
• Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
• Has a recent history of drug or alcohol dependence (since having bariatric surgery).
• Is currently in active treatment for eating or weight loss.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale Department of Psychiatry

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Naltrexone; bupropion hydrochloride, naltrexone hydrochoride drug combination

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 22, 2020
• Study Start: June 29, 2021
• Primary Completion: December 12, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)