search
Back to results

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

Primary Purpose

Loss-of-Control Eating, Obesity/Overweight

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone and Bupropion (NB) medication
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Loss-of-Control Eating

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

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.

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naltrexone+Bupropion Medication

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
Body Mass Index (BMI)
BMI is calculated using measured height and weight
Body Mass Index (BMI)
BMI is calculated using measured height and weight
Body Mass Index (BMI)
BMI is calculated using measured height and weight

Secondary Outcome Measures

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.
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.
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.
Eating Disorder Psychopathology
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Eating Disorder Psychopathology
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Eating Disorder Psychopathology
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).

Full Information

First Posted
October 21, 2020
Last Updated
August 30, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT04605081
Brief Title
Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Official Title
Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss-of-Control Eating, Obesity/Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naltrexone+Bupropion Medication
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Naltrexone and Bupropion (NB) medication
Other Intervention Name(s)
Contrave
Intervention Description
NB medication will be taken daily in pill form.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be inactive and taken daily in pill form.
Primary Outcome Measure Information:
Title
Loss-of-control eating Relapse
Description
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.
Time Frame
From baseline interview at study enrollment to after the 12-week treatment
Title
Loss-of-control eating Relapse
Description
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.
Time Frame
From post-treatment to the 6-month follow-up
Title
Loss-of-control eating Relapse
Description
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.
Time Frame
From post-treatment to the 12-month follow-up
Title
Body Mass Index (BMI)
Description
BMI is calculated using measured height and weight
Time Frame
From baseline at study enrollment to after the 12-week treatment
Title
Body Mass Index (BMI)
Description
BMI is calculated using measured height and weight
Time Frame
From post-treatment to the 6-month follow-up
Title
Body Mass Index (BMI)
Description
BMI is calculated using measured height and weight
Time Frame
From post-treatment to the 12-month follow-up
Secondary Outcome Measure Information:
Title
Loss-of-control eating Frequency
Description
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.
Time Frame
From baseline interview at study enrollment to after the 12-week treatment
Title
Loss-of-control eating Frequency
Description
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.
Time Frame
From post-treatment to the 6-month follow-up
Title
Loss-of-control eating Frequency
Description
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.
Time Frame
From post-treatment to the 12-month follow-up
Title
Eating Disorder Psychopathology
Description
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time Frame
From baseline interview at study enrollment to after the 12-week treatment
Title
Eating Disorder Psychopathology
Description
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time Frame
From post-treatment to the 6-month follow-up
Title
Eating Disorder Psychopathology
Description
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time Frame
From post-treatment to the 12-month follow-up
Title
Depressive Symptoms
Description
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Time Frame
From baseline at study enrollment to after the 12-week treatment
Title
Depressive Symptoms
Description
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Time Frame
From post-treatment to the 6-month follow-up
Title
Depressive Symptoms
Description
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Time Frame
From post-treatment to the 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Ivezaj, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs