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

Obesity/Overweight Clinical Trial

Official title:

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04599478
• Other study ID #: 2000029057
• Secondary ID: R01DK126637-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 29, 2021
• Est. completion date: January 2027

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: Valentina Ivezaj, Ph.D.
• Phone: 203-785-7210
• Email: valentina.ivezaj[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Loss-of-control Eating
• Obesity/Overweight
• Overweight

Intervention

Drug:
• Naltrexone and Bupropion medication
NB medication will be taken daily in pill form.

Behavioral:
• Behavioral Weight Loss
Behavioral Weight Loss (BWL) counseling includes weekly sessions.

Other:
• Placebo
Placebo will be inactive and taken daily in pill form.

Locations

Country	Name	City	State
United States	Yale Department of Psychiatry	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Body Mass Index	BMI is calculated using measured height and weight	Post-treatment (4 months)
Secondary	Loss-of-control Eating Remission	Categorical: zero episodes/28 days	Post-treatment (4 months)
Secondary	Weight loss	Categorical: 5% weight loss	Post-treatment (4 months)
Secondary	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).	Post-treatment (4 months)
Secondary	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).	Post-treatment (4 months)