Trial · NCT04605081
Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
NCT04605081, Phase 2, Phase 3, Completed, Yale University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a). Trials, record NCT04605081. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04605081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
- NCT number
- NCT04605081
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 24 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Loss-of-Control Eating, Obesity/Overweight
- Interventions
- Naltrexone and Bupropion (NB) medication, Placebo
- First posted
- 2020-10-27
- Last updated
- 2026-08-26
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Loss-of-control Eating Relapse | At post-treatment after the 12-week treatment | 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. |
| Primary | Loss-of-control Eating Relapse | From post-treatment to the 6-month follow-up | 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. |
| Primary | Loss-of-control Eating Relapse | From post-treatment to the 12-month follow-up | 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. |
| Primary | Percent Weight Change | From baseline at study enrollment to after the 12-week treatment | Percent weight loss is calculated based on change from pre-treatment to post-treatment at 12 weeks. Negative values indicate weight loss. |
| Primary | Percent Weight Change | From post-treatment to the 6-month follow-up | Percent weight loss is calculated based on change from post-treatment to the 6-month follow-up. Negative values indicate weight loss. |
| Primary | Percent Weight Change | From post-treatment to the 12-month follow-up | Percent weight loss is calculated based on change from post-treatment to the 12-month follow-up. Negative values indicate weight loss. |
| Secondary | Loss-of-control Eating Frequency | At post-treatment after the 12-week treatment | 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. |
| Secondary | Loss-of-control Eating Frequency | 6-month follow-up after the end of treatment | 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. |
| Secondary | Loss-of-control Eating Frequency | 12-month follow-up after the end of treatment | 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. |
| Secondary | Eating Disorder Psychopathology | At post-treatment after the 12-week treatment | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01DK126637 | Using a SMART Design to Examine Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes after Metabolic and Bariatric Surgery | GRILO, CARLOS M | YALE UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2020 to 2025 | NIH RePORTER |
| R03AA028361 | Does endotoxin administration increase alcohol consumption in individuals with AUD? | VERPLAETSE, TERRIL L | YALE UNIVERSITY | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2021 to 2022 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04605081
GET https://conductscience.org/api/trials/v1/NCT04605081/registered