Phase 3
N=31
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
Binge-Eating Disorder · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03063606 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Binge Eating Frequency (Continuous) — 0.8; 12.1 Eating events/28 days — p=.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cognitive-Behavioral Therapy (CBT) (Behavioral); NB Medication (on-going from acute treatment) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Binge Eating Frequency (Continuous) |
1.70 | — |
| PRIMARY Change in Body Mass Index at 4 Months Post-Treatment From Baseline |
-0.16; -1.18 | .83 |
| SECONDARY Binge Eating Frequency (Continuous) |
1.70 | — |
| SECONDARY Binge Eating Frequency (Continuous) |
1.70 | — |
Summary
This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .
Eligibility Criteria
Inclusion Criteria
- Participated in acute treatment for binge-eating disorder and obesity;
- Did not have 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 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 (NCT03063606). 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.