Weight Regain Treatment Post-Bariatric Surgery
A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study
1 other identifier
interventional
26
1 country
1
Brief Summary
This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 10, 2020
CompletedStudy Start
First participant enrolled
August 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2022
CompletedResults Posted
Study results publicly available
November 13, 2023
CompletedNovember 13, 2023
October 1, 2023
1.1 years
December 9, 2020
October 19, 2023
October 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Body Mass Index
BMI is calculated using measured height and weight- kg/m2.
Post-treatment (3 months)
Secondary Outcomes (3)
Eating Disorder Psychopathology
Post-treatment (3 months)
Food Craving
Post-treatment (3 months)
Depressive Symptoms
Post-treatment (3 months)
Study Arms (2)
Behavioral Weight Loss
EXPERIMENTALBehavioral Weight Loss + Medication
EXPERIMENTALInterventions
All participants will receive twelve weeks of BWL treatment.
Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
Eligibility Criteria
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 kg/m2
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- Experiencing weight regain after bariatric surgery
- 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 3 months.
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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- American Psychological Foundationcollaborator
Study Sites (1)
Yale University
New Haven, Connecticut, 06511, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Valentina Ivezaj, Assistant Professor of Psychiatry
- Organization
- Yale School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 10, 2020
Study Start
August 5, 2021
Primary Completion
September 13, 2022
Study Completion
September 13, 2022
Last Updated
November 13, 2023
Results First Posted
November 13, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share