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NCT04605081 · ClinicalTrials.gov registry record · Phase 2
Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
A Phase 2 study of Obesity & Overweight and Loss-of-control Eating, sponsored by Yale University.
- Active
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04605081: Active Phase 2 study of Obesity & Overweight and Loss-of-control Eating, sponsored by Yale University.
NCT04605081 is a Phase 2 study of Obesity & Overweight and Loss-of-control Eating that is active but no longer recruiting, run by Yale University. The registered enrollment target is 100 participants, below the 112-participant average among 28 other Obesity & Overweight trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04605081, a Phase 2 study of Obesity & Overweight and Loss-of-control Eating, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Naltrexone and Bupropion (NB) medication
Study Locations (1)
Connecticut
- Yale School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-01-10 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What the registry record for NCT04605081 still lists
NCT04605081 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 112-participant average among 28 other Obesity & Overweight trials with a reported enrollment target (11% lower).
The record links to 2 conditions, with Obesity & Overweight appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04605081 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04605081 about?
NCT04605081 is a clinical study titled "Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)". This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication re...
What is the current status of trial NCT04605081?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2022-01-10. Estimated completion is 2027-05.
What conditions does trial NCT04605081 study?
This clinical trial studies the following conditions: Obesity & Overweight, Loss-of-control Eating.
What interventions are being tested in trial NCT04605081?
The interventions under investigation include: Placebo (OTHER), Naltrexone and Bupropion (NB) medication (DRUG).
Who is sponsoring clinical trial NCT04605081?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04605081 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity & Overweight
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04605081's enrollment target sits among peer trials
100 11th of 28 higher than 18 of 28 other Obesity & Overweight trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity & Overweight trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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