Phase 3
Completed N=136
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
Source: ClinicalTrials.gov NCT03045341 ↗Enrolled (actual)
136
Serious AEs
0.9%
Results posted
Dec 2022
Primary outcomePrimary: Binge Eating Frequency (Continuous) — 9.90; 7.63; 3.30; 1.97 binge-eating episodes per month — p=0.0001
◆ Published Evidence
Established
88citations · ~22 / year
Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial.
Summary
This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.
Linked Publications
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Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Eating Frequency (Continuous) |
9.90; 7.63; 3.30; 1.97 | 0.0001 sig |
| PRIMARY Body Mass Index (Percent Weight Loss) |
1.05; -2.11; -4.42; -5.71 | 0.0001 sig |
| SECONDARY Number of Participants Meeting Response Criteria |
14; 14; 20; 25 | .004 sig |
Eligibility Criteria
Inclusion Criteria
- Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
- 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;
- Able to travel to study location (New Haven, CT) for weekly 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 (NCT03045341) and the linked publication. 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.