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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00320047

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eating Disorders Bulimia Nervosa	Drug: Baclofen	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Baclofen on Binge Eating in Bulimia Nervosa and Binge Eating Disorder

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will take baclofen for 10 weeks.	Drug: Baclofen 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.

Arm

Intervention/Treatment

Experimental: 1

Participants will take baclofen for 10 weeks.

Drug: Baclofen

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.

Outcome Measures

Primary Outcome Measures

Frequency of binge eating [Measured at Week 13]

Secondary Outcome Measures

Cravings associated with binge eating [Measured at Week 13]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For people with BN:

Meets DSM-IV criteria for BN
Disease duration is more than 1 year
Self-induces vomiting
Weighs between 80 and 120% of ideal weight
Binge eats on at least 6 days during the 2-week run-in period

For obese people with BED:

Meets DSM-IV criteria for BED
Obese (body mass index [BMI] is greater than 30 kg/m²)
Binge eats on at least 6 days during the 2-week run-in period

Exclusion Criteria:

For all participants:

Significant medical illness
Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
Moderate to severe depression as defined by a score greater than 18 on the Hamilton Depression Scales
Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures
At risk for suicide
Currently taking medication other than birth control pills or over-the-counter medication
History of drug or alcohol abuse within 3 months prior to study entry
Pregnant, planning to become pregnant, or breast feeding
Known intolerance to baclofen, or related muscle relaxants
Orthostatic hypotension