Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)

NCT04605081 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000029057a5R01DK126637-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity/Overweight; Loss-of-Control Eating

Outcome Measures

Primary Outcomes (6)

• Loss-of-control eating Relapse

  Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.

  From baseline interview at study enrollment to after the 12-week treatment

• Loss-of-control eating Relapse

  Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.

  From post-treatment to the 6-month follow-up

• Loss-of-control eating Relapse

  Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.

  From post-treatment to the 12-month follow-up

• Body Mass Index (BMI)

  BMI is calculated using measured height and weight

  From baseline at study enrollment to after the 12-week treatment

• Body Mass Index (BMI)

  BMI is calculated using measured height and weight

  From post-treatment to the 6-month follow-up

• Body Mass Index (BMI)

  BMI is calculated using measured height and weight

  From post-treatment to the 12-month follow-up

Secondary Outcomes (9)

• Loss-of-control eating Frequency

  From baseline interview at study enrollment to after the 12-week treatment

• Loss-of-control eating Frequency

  From post-treatment to the 6-month follow-up

• Loss-of-control eating Frequency

  From post-treatment to the 12-month follow-up

• Eating Disorder Psychopathology

  From baseline interview at study enrollment to after the 12-week treatment

• Eating Disorder Psychopathology

  From post-treatment to the 6-month follow-up

Study Arms (2)

Naltrexone+Bupropion Medication

EXPERIMENTAL

Drug: Naltrexone and Bupropion (NB) medication

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

Placebo will be inactive and taken daily in pill form.

Placebo

Naltrexone and Bupropion (NB) medication DRUG

NB medication will be taken daily in pill form.

Also known as: Contrave

Naltrexone+Bupropion Medication

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 had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
• Approximately ten months post-surgery
• Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment responders to a four-month treatment trial of medication and/or BWL
• 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 15 months (3-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

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

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Naltrexone; Bupropion; Dosage Forms; 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; Propiophenones; Ketones; Organic Chemicals; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Valentina Ivezaj, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

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 27, 2020
• Study Start: January 10, 2022
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)