Clinical Trial: Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Baclofen on Binge Eating in Bulimia Nervosa and Binge Eating Disorder
Brief Summary: This study will evaluate the effectiveness of the drug baclofen in reducing binge eating and associated food cravings in people with bulimia nervosa or binge eating disorder.
Detailed Summary:
Bulimia nervosa (BN) and binge eating disorder (BED) are serious eating disorders that are characterized by frequent uncontrolled eating binges. Binge eating is associated with both psychological and physical health problems, such as depression, obesity, stomach problems, and heart problems. Treatment options for binge eating, however, are limited. Baclofen, a drug that enhances the GABA-B neurotransmitter's ability to inhibit neuronal activity in the brain, is commonly used as a muscle relaxant. It has also been shown, however, to have positive effects on binge eating when used in animals and on substance abuse when used in humans. This study will evaluate the effectiveness of baclofen in reducing binge eating and associated food cravings in people with BN or BED.
People interested in participating in this study will first report to the study site for two initial visits, which will involve blood tests and interviews regarding medical history. If eligible, participants will take part in this 13-week open-label study. Participants will take baclofen 3 times a day, before meals, for 10 weeks. Baclofen dosages will be low to begin, followed by a gradual increase over a 2-week period. Upon reaching the maximum tolerated dose of baclofen, participants will continue at this dosage level until Week 11, at which time the dose will be gradually decreased. If any serious side effects occur, baclofen dosage will be decreased to the previous tolerated dosage level. Participants will also keep a daily record of any episodes of binge eating. Study visits will be held biweekly. At each visit, participants will be interviewed by a psychiatrist about their mental health history and eating patterns, and will fill out questionnaires about their eating habits, emotional states, and any side effects. Phone interviews will be conducted during the weeks in between study visits.
Sponsor: New York State Psychiatric Institute
Current Primary Outcome: Frequency of binge eating [ Time Frame: Measured at Week 13 ]
Original Primary Outcome: Measured at Week 13: Frequency of binge eating
Current Secondary Outcome: Cravings associated with binge eating [ Time Frame: Measured at Week 13 ]
Original Secondary Outcome: Measured at Week 13: Cravings associated with binge eating
Information By: New York State Psychiatric Institute
Dates:
Date Received: April 28, 2006
Date Started: April 2005
Date Completion:
Last Updated: August 8, 2013
Last Verified: September 2008
