Trials / Completed
CompletedNCT03063606
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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 .
Detailed description
Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (specialist treatment) RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether cognitive-behavioral therapy augments on-going blinded pharmacotherapy (naltrexone/bupropion or placebo) compared with on-going pharmacotherapy alone (without added cognitive-behavioral therapy).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive-Behavioral Therapy (CBT) | CBT specialist treatment |
| DRUG | NB Medication (on-going from acute treatment) | Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo) |
Timeline
- Start date
- 2017-09-05
- Primary completion
- 2021-12-01
- Completion
- 2022-12-16
- First posted
- 2017-02-24
- Last updated
- 2024-02-01
- Results posted
- 2023-07-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03063606. Inclusion in this directory is not an endorsement.