Clinical trial NCT03047005: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy
Official title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Binge-Eating Disorder
Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-02-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

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 (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Eligibility criteria: Inclusion Criteria:

* Participated in acute treatment for binge-eating disorder and obesity;
* Had 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 monthly 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.

Primary outcomes:
measure: Binge Eating Frequency (Continuous)
timeFrame: Post-treatment (4 months)
measure: Change in Body Mass Index
timeFrame: baseline and Post-treatment (4 months)
Secondary outcomes:
measure: Binge Eating Frequency (Continuous)
timeFrame: 6-Month Follow-up
measure: Binge Eating Frequency (Continuous)
timeFrame: 12-Month Follow-up
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline to 6-Month Follow-up
measure: Change in Body Mass Index
timeFrame: Baseline to 12-Month Follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos M Grilo, PhD
role: PRINCIPAL_INVESTIGATOR
References: