Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder
Condition: Eating Disorders; Bulimia Nervosa
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

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 description: 
      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.
    

Intervention name(s): Baclofen
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Baclofen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Binge Eating Disorder