Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder
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|ClinicalTrials.gov Identifier: NCT00320047|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : August 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Eating Disorders Bulimia Nervosa||Drug: Baclofen||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Baclofen on Binge Eating in Bulimia Nervosa and Binge Eating Disorder|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2007|
Participants will take baclofen for 10 weeks.
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.
- Frequency of binge eating [ Time Frame: Measured at Week 13 ]
- Cravings associated with binge eating [ Time Frame: Measured at Week 13 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320047
|United States, New York|
|Eating Disorders Clinic, New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||B. T. Walsh, MD||New York State Psychiatric Institute at Columbia University Medical Center|