Binge-Eating Disorder
Conditions
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.
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.
Interventions
DRUGBupropion 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.
OTHERPlacebo
Placebo will be inactive and taken daily in pill form.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition); * BMI in the obesity (BMI \>30 and \<50) or non-obesity (BMI \>21.5 and \<29.9) range; * Available for the duration of the treatment and follow-up (15 months); * Read, comprehend, and write English at a sufficient level to complete study-related materials.
Exclusion criteria
* Currently taking opioid pain medications or drugs; or positive drug screen for opiates * 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 or bulimia nervosa; * Pregnant or breastfeeding; * Medical status judged by study physician as contraindication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Binge Eating Frequency | Post-treatment (3 months) | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment. |
| Percent BMI Change | Post-treatment (3 months) | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Binge Eating Frequency | 6 months post-treatment | Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment. |
| Body Mass Index | 6 months post-treatment | BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 6 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NB Medication Naltrexone Hydrochoride, Bupropion Hydrochloride Drug Combination (NB Medication)
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. | 43 |
| Placebo Placebo will be inactive and taken daily in pill form.
Placebo: Placebo will be inactive and taken daily in pill form. | 46 |
| Total | 89 |
Baseline characteristics
| Characteristic | Total | NB Medication | Placebo |
|---|---|---|---|
| Age, Continuous | 45.7 years STANDARD_DEVIATION 13.5 | 45.3 years STANDARD_DEVIATION 14 | 46.0 years STANDARD_DEVIATION 13.2 |
| Education College | 16 Participants | 12 Participants | 4 Participants |
| Education High School | 16 Participants | 8 Participants | 8 Participants |
| Education More than College | 23 Participants | 9 Participants | 14 Participants |
| Education Some College | 34 Participants | 14 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 40 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 62 Participants | 31 Participants | 31 Participants |
| Region of Enrollment United States | 89 participants | 43 participants | 46 participants |
| Sex/Gender, Customized Another gender | 2 Participants | 2 Participants | 0 Participants |
| Sex/Gender, Customized Men | 24 Participants | 11 Participants | 13 Participants |
| Sex/Gender, Customized Women | 63 Participants | 30 Participants | 33 Participants |
| Sexual Orientation Bisexual | 6 Participants | 3 Participants | 3 Participants |
| Sexual Orientation Heterosexual | 80 Participants | 38 Participants | 42 Participants |
| Sexual Orientation Homosexual | 3 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 46 |
| other Total, other adverse events | 26 / 43 | 26 / 46 |
| serious Total, serious adverse events | 0 / 43 | 0 / 46 |
Outcome results
Primary
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing baseline and post-treatment. Change is defined as the change in frequency from baseline to post-treatment.
Time frame: Post-treatment (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Change in Binge Eating Frequency | 6.4 binge-eating episodes per month | Standard Deviation 10.6 |
| Placebo | Change in Binge Eating Frequency | 5.4 binge-eating episodes per month | Standard Deviation 9.6 |
p-value: 0.44Mixed Models Analysis
Primary
Percent BMI Change
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at posttreatment\] - \[BMI at baseline\])/\[BMI at baseline\]. Negative values indicate loss.
Time frame: Post-treatment (3 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Percent BMI Change | -8.0 percent BMI change | Standard Deviation 11.3 |
| Placebo | Percent BMI Change | -0.5 percent BMI change | Standard Deviation 8.9 |
p-value: 0.04Mixed Models Analysis
Secondary
Body Mass Index
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 6 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Time frame: 6 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Body Mass Index | 0.04 percent BMI change | Standard Deviation 10.51 |
| Placebo | Body Mass Index | 0.05 percent BMI change | Standard Deviation 4.28 |
p-value: 0.99ANOVA
Secondary
Body Mass Index
BMI was calculated using measured height and weight. We report percent BMI change using the following formula: (\[BMI at 12 month followup\] - \[BMI at posttreatment\])/\[BMI at posttreatment\]. Negative values indicate loss.
Time frame: 12 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Body Mass Index | -0.20 percent BMI change | Standard Deviation 12.18 |
| Placebo | Body Mass Index | 3.43 percent BMI change | Standard Deviation 7.86 |
p-value: 0.4ANOVA
Secondary
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 6 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 6 months post-treatment.
Time frame: 6 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Change in Binge Eating Frequency | 4.67 binge-eating episodes per month | Standard Deviation 6.29 |
| Placebo | Change in Binge Eating Frequency | 6.00 binge-eating episodes per month | Standard Deviation 9.54 |
p-value: 0.98ANOVA
Secondary
Change in Binge Eating Frequency
Binge eating will be assessed by interview (Eating Disorder Examination) and the primary outcome is frequency of binge episodes in the past month, comparing post-treatment and 12 month post-treatment follow up. Change is defined as the change in frequency from post-treatment to 12 months post-treatment.
Time frame: 12 months post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NB Medication | Change in Binge Eating Frequency | 6.36 binge-eating episodes per month | Standard Deviation 14.87 |
| Placebo | Change in Binge Eating Frequency | 5.33 binge-eating episodes per month | Standard Deviation 6.82 |
p-value: 0.44ANOVA