Loss-of-control EatingPhase 2/3NCT04599478
Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)
A Phase 2/3 study testing Naltrexone and Bupropion medication and Behavioral Weight Loss in people with Loss-of-control Eating and Obesity/Overweight, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Loss-of-control Eating, Obesity/Overweight
- What is being tested?
- Naltrexone and Bupropion medication and Behavioral Weight Loss
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 4 Jun 2026
- 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
- 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).
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- 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).
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.
United States1 site
Yale Department of Psychiatry
New Haven, Connecticut, 06510
About this study
Official title: Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)
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.
Read the 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
- Being tested
- Naltrexone and Bupropion medication, Behavioral Weight Loss, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone and Bupropion medicationDrug
Also called Contrave
NB medication will be taken daily in pill form.
Behavioral Weight LossBehavioural
Behavioral Weight Loss (BWL) counseling includes weekly sessions.
PlaceboOther
Placebo will be inactive and taken daily in pill form.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication | Experimental | 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. Receives: Drug: Naltrexone and Bupropion medication; Behavioral: Behavioral Weight Loss |
| BWL + Placebo | Experimental | 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. Receives: Behavioral: Behavioral Weight Loss; Other: Placebo |
| NB medication | Experimental | Participants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form. Receives: Drug: Naltrexone and Bupropion medication |
| Placebo | Placebo comparator | Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-treatment (4 months)
Percent Weight Loss
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 4 months. Negative values indicate weight loss.
Measured: Post-treatment (4 months)
Secondary outcomes (4)
Number of Participants With Loss-of-control Eating Remission
Categorical: zero episodes/28 days
Measured: Post-treatment (4 months)
Number of Participants With 5% Weight Loss
Categorical: 5% weight loss
Measured: Post-treatment (4 months)
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 (4 months)
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).
Measured: Post-treatment (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start29 Jun 2021
- Primary completion4 Jun 2026
- Study completion4 Jun 2026
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 Loss-of-control EatingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04599478
- Sponsor's protocol ID
- 2000029057
- Other IDs
- R01DK126637-01
- Status last verified
- Aug 2026
- First submitted
- 21 Oct 2020
- Last updated
- 26 Aug 2026
- 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)
- ClinicalTrials.gov ID
- NCT04599478
- Acronym / sponsor ID
- 2000029057
- Conditions
- Loss-of-control Eating, Obesity/Overweight
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 4 Jun 2026 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Posted 26 Aug 2026
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication | Experimental | Drug: Naltrexone and Bupropion medication, Behavioral: Behavioral Weight LossParticipants 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. |
| BWL + Placebo | Experimental | Behavioral: Behavioral Weight Loss, Other: PlaceboParticipants randomly assigned to this arm will receive 16 weeks of BWL counseling and placebo. Placebo will be inactive and taken daily in pill form. |
| NB medication | Experimental | Drug: Naltrexone and Bupropion medicationParticipants randomly assigned to this arm will receive 16 weeks of NB medication taken daily in pill form. |
| Placebo | Placebo comparator | Other: PlaceboParticipants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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
- 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)
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 |
|---|---|---|
| Naltrexone and Bupropion medicationAlso: ContraveNB medication will be taken daily in pill form. | Drug | Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication, NB medication |
| Behavioral Weight LossBehavioral Weight Loss (BWL) counseling includes weekly sessions. | Behavioural | BWL + Placebo, Behavioral Weight Loss (BWL) + Naltrexone and Bupropion (NB) medication |
| PlaceboPlacebo will be inactive and taken daily in pill form. | Other | BWL + Placebo, Placebo |
Primary outcome
Loss-of-control Eating Frequency
Time frame: Post-treatment (4 months)
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.
Percent Weight Loss
Time frame: Post-treatment (4 months)
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 4 months. Negative values indicate weight loss.
4 secondary outcomes
Number of Participants With Loss-of-control Eating Remission
Time frame: Post-treatment (4 months)
Number of Participants With 5% Weight Loss
Time frame: Post-treatment (4 months)
Eating Disorder Psychopathology
Time frame: Post-treatment (4 months)
Depressive Symptoms
Time frame: Post-treatment (4 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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 Naltrexone and Bupropion medication and Behavioral Weight Loss in people with Loss-of-control Eating and 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 9 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 26 Aug 2026. 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. Some participants in this study may receive a placebo. 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 26 Aug 2026). 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?
Loss-of-control Eating Frequency (time frame: Post-treatment (4 months)). The study lists 2 primary outcomes in all. 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 26 Aug 2026.