Clinical trial NCT00414167: Craving, Binge Eating and Obesity
Official title: Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Binge Eating Disorder
Obesity
Keywords: Binge eating
Obesity
Medication
Craving
Emotional eating
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-12-21
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Frequency of Binge Eating Episodes
timeFrame: One week (at post treatment)
Secondary outcomes:
measure: Percent BMI Loss
timeFrame: 8 weeks (baseline and 8 weeks)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Marney A. White, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Apr;74(4):400-6. doi: 10.4088/JCP.12m08071.