Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Specialist Treatment



Status:Enrolling by invitation
Conditions:Obesity Weight Loss, Psychiatric
Therapuetic Areas:Endocrinology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 70
Updated:1/11/2018
Start Date:September 5, 2017
End Date:October 2023

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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

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 .

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).

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