Craving, Binge Eating and Obesity

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity; Binge Eating Disorder

Treatments: Drug: bupropion; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00414167

0511000832

K23DK071646 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Bupropion

Treatment:

Drug: bupropion

2

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo