Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Study Details
Study Description
Brief Summary
This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2/Phase 3 |
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 BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: NB Medication Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination |
Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
Other Names:
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Placebo Comparator: Placebo Placebo will be inactive and taken daily in pill form. |
Other: Placebo
Placebo will be inactive and taken daily in pill form.
|
Outcome Measures
Primary Outcome Measures
- Binge Eating Frequency [Post-treatment (3 months)]
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
- Binge Eating Frequency [6 months post-treatment]
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
- Binge Eating Frequency [12 months post-treatment]
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Secondary Outcome Measures
- Body Mass Index [Post-treatment (3 months)]
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.
- Body Mass Index [6 months post-treatment]
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.
- Body Mass Index [12 months post-treatment]
BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
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BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;
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Available for the duration of the treatment and follow-up (15 months);
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Read, comprehend, and write English at a sufficient level to complete study-related materials.
Exclusion Criteria:
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Currently taking opioid pain medications or drugs; or positive drug screen for opiates
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Currently taking medications that influence eating/weight;
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History of seizures;
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Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
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Past or current anorexia nervosa or bulimia nervosa;
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Pregnant or breastfeeding;
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Medical status judged by study physician as contraindication.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Yale School of Medicine | New Haven | Connecticut | United States | 06520 |
Sponsors and Collaborators
- Yale University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Carlos M Grilo, PhD, Yale School of Medicine
- Principal Investigator: Sherry McKee, PhD, Yale School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000021769
- R01DK112771