Binge-eating Disorder, Obesity
Conditions
Brief 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.
Detailed description
Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity.
Interventions
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binge Eating Frequency (Continuous) | Post-treatment (4 months) | Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally). |
| Body Mass Index (Percent Weight Loss) | Post-treatment (4 months) | BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Meeting Response Criteria | Post-treatment (4 months) | Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
Placebo: Placebo | 34 |
| NB Medication Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
NB medication (Naltrexone Bupropion combination): NB medication | 32 |
| BWL + Placebo Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral Weight Loss (BWL) counseling: BWL counseling
Placebo: Placebo | 35 |
| BWL + NB Medication Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
NB medication (Naltrexone Bupropion combination): NB medication
Behavioral Weight Loss (BWL) counseling: BWL counseling | 35 |
| Total | 136 |
Baseline characteristics
| Characteristic | NB Medication | Total | BWL + NB Medication | BWL + Placebo | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 46.03 years STANDARD_DEVIATION 11.95 | 46.50 years STANDARD_DEVIATION 12.23 | 46.99 years STANDARD_DEVIATION 12.98 | 46.00 years STANDARD_DEVIATION 11.87 | 46.94 years STANDARD_DEVIATION 12.57 |
| Education College | 7 Participants | 32 Participants | 10 Participants | 5 Participants | 10 Participants |
| Education High School | 5 Participants | 21 Participants | 5 Participants | 4 Participants | 7 Participants |
| Education More than College | 14 Participants | 43 Participants | 9 Participants | 12 Participants | 8 Participants |
| Education Some College | 6 Participants | 40 Participants | 11 Participants | 14 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 20 Participants | 4 Participants | 5 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 116 Participants | 31 Participants | 30 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 18 Participants | 4 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 106 Participants | 29 Participants | 26 Participants | 26 Participants |
| Sex/Gender, Customized Female | 26 Participants | 111 Participants | 29 Participants | 28 Participants | 28 Participants |
| Sex/Gender, Customized Male | 5 Participants | 22 Participants | 6 Participants | 5 Participants | 6 Participants |
| Sex/Gender, Customized Other | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants |
| Sexual Orientation Bisexual | 2 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sexual Orientation Gay or Lesbian | 0 Participants | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sexual Orientation Heterosexual | 29 Participants | 125 Participants | 33 Participants | 33 Participants | 30 Participants |
| Sexual Orientation Other | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 27 | 0 / 29 | 0 / 31 |
| other Total, other adverse events | 18 / 31 | 24 / 27 | 20 / 29 | 24 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 27 | 1 / 29 | 0 / 31 |
Outcome results
Primary
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Time frame: Post-treatment (4 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Binge Eating Frequency (Continuous) | 9.90 binge-eating episodes per month | Standard Deviation 20.31 |
| NB Medication | Binge Eating Frequency (Continuous) | 7.63 binge-eating episodes per month | Standard Deviation 9.77 |
| BWL + Placebo | Binge Eating Frequency (Continuous) | 3.30 binge-eating episodes per month | Standard Deviation 5.28 |
| BWL + NB Medication | Binge Eating Frequency (Continuous) | 1.97 binge-eating episodes per month | Standard Deviation 4.87 |
Comparison: BWL versus no BWLp-value: 0.0001Mixed Models Analysis
Comparison: NB versus placebop-value: 0.58Mixed Models Analysis
Primary
Body Mass Index (Percent Weight Loss)
BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.
Time frame: Post-treatment (4 months)
Population: Analyses used all available data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Body Mass Index (Percent Weight Loss) | 1.05 percentage of baseline weight | Standard Deviation 4.26 |
| NB Medication | Body Mass Index (Percent Weight Loss) | -2.11 percentage of baseline weight | Standard Deviation 5.41 |
| BWL + Placebo | Body Mass Index (Percent Weight Loss) | -4.42 percentage of baseline weight | Standard Deviation 5.7 |
| BWL + NB Medication | Body Mass Index (Percent Weight Loss) | -5.71 percentage of baseline weight | Standard Deviation 5.85 |
Comparison: BWL versus no BWLp-value: 0.0001Mixed Models Analysis
Comparison: NB versus placebop-value: 0.63Mixed Models Analysis
Secondary
Number of Participants Meeting Response Criteria
Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment). Response to treatment is defined as a 65% reduction in binge eating frequency in past month, compared to baseline.
Time frame: Post-treatment (4 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Meeting Response Criteria | 14 Participants |
| NB Medication | Number of Participants Meeting Response Criteria | 14 Participants |
| BWL + Placebo | Number of Participants Meeting Response Criteria | 20 Participants |
| BWL + NB Medication | Number of Participants Meeting Response Criteria | 25 Participants |
Comparison: Analyses used all available data.p-value: 0.004Chi-squared