Obesity, OverweightPhase 2/3NCT04662801
Weight Regain Treatment Post-Bariatric Surgery
A Phase 2/3 study testing Behavioral Weight Loss (BWL), Early Responder: BWL continued and Early Non-responder: BWL continued with medication added in people with Obesity, Overweight, run by Yale University at 1 site in United States.
Trial summary
This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Behavioral Weight Loss (BWL), Early Responder: BWL continued and Early Non-responder: BWL continued with medication added
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 13 Sep 2022
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study
This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.
- Conditions
- Obesity, Overweight
- Being tested
- Behavioral Weight Loss (BWL), Early Responder: BWL continued, Early Non-responder: BWL continued with medication added
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Weight Loss (BWL)Behavioural
All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continuedBehavioural
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.
Early Non-responder: BWL continued with medication addedCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss | Experimental | Not described Receives: Behavioral: Behavioral Weight Loss (BWL); Behavioral: Early Responder: BWL continued |
| Behavioral Weight Loss + Medication | Experimental | Not described Receives: Behavioral: Behavioral Weight Loss (BWL); Combination Product: Early Non-responder: BWL continued with medication added |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
BMI is calculated using measured height and weight- kg/m2.
Measured: Post-treatment (3 months)
Secondary outcomes (3)
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).
Measured: Post-treatment (3 months)
Food Craving
Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.
Measured: Post-treatment (3 months)
Depressive Symptoms
Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology
Measured: Post-treatment (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start5 Aug 2021
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, OverweightStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662801
- Sponsor's protocol ID
- 2000029491
- Status last verified
- Oct 2023
- First submitted
- 9 Dec 2020
- Last updated
- 13 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT04662801
- Acronym / sponsor ID
- 2000029491
- Conditions
- Obesity, Overweight
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Psychological Foundation
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Posted 13 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss | Experimental | Behavioral: Behavioral Weight Loss (BWL), Behavioral: Early Responder: BWL continued |
| Behavioral Weight Loss + Medication | Experimental | Behavioral: Behavioral Weight Loss (BWL), Combination Product: Early Non-responder: BWL continued with medication added |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Weight Loss (BWL)All participants will receive twelve weeks of BWL treatment. | Behavioural | Behavioral Weight Loss, Behavioral Weight Loss + Medication |
| Early Responder: BWL continuedParticipants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment. | Behavioural | Behavioral Weight Loss |
| Early Non-responder: BWL continued with medication addedParticipants 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. | Combination product | Behavioral Weight Loss + Medication |
Primary outcome
Body Mass Index
Time frame: Post-treatment (3 months)
BMI is calculated using measured height and weight- kg/m2.
3 secondary outcomes
Eating Disorder Psychopathology
Time frame: Post-treatment (3 months)
Food Craving
Time frame: Post-treatment (3 months)
Depressive Symptoms
Time frame: Post-treatment (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Behavioral Weight Loss (BWL), Early Responder: BWL continued and Early Non-responder: BWL continued with medication added in people with Obesity, Overweight, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Post-treatment (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.