Phase 3
Completed N=66
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Source: ClinicalTrials.gov NCT03047005 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Binge Eating Frequency (Continuous) — 0.86; 3.25 binge eating days per month — p=.07
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Eating Frequency (Continuous) |
3.35; 2.77 | — |
| PRIMARY Change in Body Mass Index |
.025; .042 | — |
| SECONDARY Binge Eating Frequency (Continuous) |
3.35; 2.77 | — |
| SECONDARY Change in Body Mass Index (BMI) |
.004; .026 | — |
| SECONDARY Change in Body Mass Index |
.025; .042 | — |
Eligibility Criteria
Inclusion Criteria
- Participated in acute treatment for binge-eating disorder and obesity;
- Had a positive response to acute treatment;
- Available for the duration of the treatment and follow-up (20 months);
- Read, comprehend, and write English at a sufficient level to complete study-related materials; and
- Able to travel to study location (New Haven, CT) for monthly visits.
Exclusion Criteria
- Currently taking anti-depressant medications;
- Currently taking opioid pain medications or drugs;
- Currently taking medications that influence eating/weight;
- History of seizures;
- Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
- Past or current anorexia nervosa, bulimia nervosa;
- Pregnant or breastfeeding;
- Medical status judged by study physician as contraindication.
Data sourced from ClinicalTrials.gov (NCT03047005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.