Clinical trial NCT03063606: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment
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: 2017-02-24
Enrollment: 31
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 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).

Eligibility criteria: Inclusion Criteria:

* Participated in acute treatment for binge-eating disorder and obesity;
* Did not have 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 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.

Primary outcomes:
measure: Binge Eating Frequency (Continuous)
timeFrame: Post-treatment (4 months)
measure: Change in Body Mass Index at 4 Months Post-Treatment From Baseline
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
Other outcomes:
measure: Body Mass Index
timeFrame: 12-Month Follow-up
measure: Body Mass Index
timeFrame: 6-Month Follow-up
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: