Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy



Status:Enrolling by invitation
Conditions:Obesity Weight Loss, Psychiatric
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:6/16/2018
Start Date:August 28, 2017
End Date:October 2023

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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

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.

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.

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.
We found this trial at
1
site
New Haven, Connecticut 06520
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mi
from
New Haven, CT
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