Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00320047
Study type	Interventional
Source	New York State Psychiatric Institute
Contact
Status	Completed
Phase	N/A
Start date	April 2005
Completion date	June 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05656859` - Prevalence of Eating Disorders Among Patients in the Department of Health Promotion
Completed	`NCT04085861` - Mental Health in Dancers; an Intervention Study	N/A
Recruiting	`NCT05651295` - A Precision Medicine Approach to Target Engagement for Emotion Regulation	N/A
Enrolling by invitation	`NCT04174703` - Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing	N/A
Terminated	`NCT04278755` - Binge Eating & Birth Control	Phase 2
Withdrawn	`NCT03050632` - Effects of Cognitive and Emotional Functioning on Treatment Outcomes	N/A
Completed	`NCT02484794` - Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application	N/A
Completed	`NCT02567890` - Swedish Body Project for Prevention of Eating Disorders	N/A
Completed	`NCT02252822` - Improving Treatment Engagement for Adolescents With Bulimia Nervosa	N/A
Completed	`NCT02021344` - Mental Health First Aid for College Students	N/A
Completed	`NCT00601354` - Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder	N/A
Completed	`NCT00418977` - Comparing the Effectiveness of Two Therapies to Treat Signs of Anorexia Nervosa in Adolescents	N/A
Completed	`NCT00304187` - Effectiveness of Antibiotic Treatment for Reducing Binge Eating and Improving Digestive Function in Bulimia Nervosa	Phase 2
Completed	`NCT00733525` - Effectiveness of Stepped Care Versus Best Available Care for Bulimia Nervosa	N/A
Active, not recruiting	`NCT04779216` - Effects of Romosozumab on Bone Density in Women With Anorexia Nervosa	Phase 3
Completed	`NCT04433663` - Eating Disorders, Self Regulation and Mentalization	N/A
Recruiting	`NCT05509257` - Naltrexone Neuroimaging in Teens With Eating Disorders	Early Phase 1
Completed	`NCT04509531` - Building Resilience in Cyberbullying Victims	N/A
Recruiting	`NCT05730348` - Mealtime Anxiety in Eating Disorders
Enrolling by invitation	`NCT05814653` - A Study to Evaluate Primary Care Treatment for Adolescent Eating Disorders	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms