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

NCT ID: NCT04599478

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2027-01-31

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.

Detailed Description

Participants who provide informed consent and are determined to be eligible will then participate in the study.

A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. The randomization will be in equal proportions but stratified by surgery type.

Conditions

Loss-of-control Eating; Obesity/Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Naltrexone and Bupropion medication

Intervention Type: DRUG

NB medication will be taken daily in pill form.

Behavioral Weight Loss

Intervention Type: BEHAVIORAL

Behavioral Weight Loss (BWL) counseling includes weekly sessions.

BWL + Placebo

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.

Group Type: EXPERIMENTAL

Behavioral Weight Loss

Intervention Type: BEHAVIORAL

Behavioral Weight Loss (BWL) counseling includes weekly sessions.

Placebo

Intervention Type: OTHER

Placebo will be inactive and taken daily in pill form.

NB medication

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

Group Type: EXPERIMENTAL

Naltrexone and Bupropion medication

Intervention Type: DRUG

NB medication will be taken daily in pill form.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be inactive and taken daily in pill form.

Interventions

Naltrexone and Bupropion medication

NB medication will be taken daily in pill form.

Intervention Type: DRUG

Behavioral Weight Loss

Behavioral Weight Loss (BWL) counseling includes weekly sessions.

Intervention Type: BEHAVIORAL

Placebo

Placebo will be inactive and taken daily in pill form.

Intervention Type: OTHER

Other Intervention Names

Contrave

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.
• Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device.
• Is breast-feeding or is pregnant or is not using a reliable form of birth control.
• Reports active suicidal or homicidal ideation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale Department of Psychiatry

New Haven, Connecticut, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Valentina Ivezaj, Ph.D.

Role: CONTACT

valentina.ivezaj@yale.edu

203-785-7210

Facility Contacts

Valentina Ivezaj, Ph.D.

Role: primary

valentina.ivezaj@yale.edu

203-785-7210

Other Identifiers

R01DK126637-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000029057

Identifier Type: -

Identifier Source: org_study_id