Craving, Binge Eating and Obesity
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Binge Eating Disorder; Obesity
Intervention: bupropion (Drug); Placebo (Other)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Official(s) and/or principal investigator(s):
Marney A. White, PhD, Principal Investigator, Affiliation: Yale University
Overall contact:
Abbe Boeka, PhD, Phone: 203-785-6040, Email: abbe.boeka@yale.edu
Summary
This research study is designed to look at the effectiveness of bupropion for reducing binge
eating in overweight persons with binge eating problems. Participants in the study will
receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for
eight weeks. In addition, participants will be given the option to receive 8 weeks of free
behavioral weight loss treatment. This treatment, known to be effective for reducing binge
eating and helping people lose weight, will be administered following the medication phase
and at no cost.
It is expected that compared to placebo, bupropion will produce greater reductions in binge
eating.
Clinical Details
Official title: Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Frequency of binge eating episodes
Secondary outcome: Body weight, food cravings, emotional eating
Detailed description:
The proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of
bupropion in treating overweight women with binge eating disorder (BED). Bupropion is an
antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in
obesity treatment. Since cravings and depressed mood are hypothesized to contribute to binge
eating episodes, bupropion is a promising psychopharmacological agent in treating binge
eating and reducing weight. It is hypothesized that compared to placebo, bupropion will
produce significantly greater reductions in the frequency of binge eating. Secondary goals
are to explore interrelationships between treatment and changes in cravings, frequency of
binge episodes, emotional eating, and weight loss. Following the medication phase of the
trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered
by doctoral-level psychologists specializing in eating disorders and weight management.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- BMI 25-50
- Able to travel to clinical site (New Haven, CT) for bi-weekly visits.
Exclusion Criteria:
- Predisposition to seizures
- History of anorexia or bulimia nervosa
- Current Type I or Type II diabetes mellitus
Locations and Contacts
Abbe Boeka, PhD, Phone: 203-785-6040, Email: abbe.boeka@yale.edu
Yale University School of Medicine, New Haven, Connecticut 06520, United States; Recruiting
Additional Information
Starting date: December 2005
Last updated: August 3, 2010
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