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

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

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.

Study Overview

• Status: Completed
• Conditions: Bulimia Nervosa; Eating Disorders
• Intervention / Treatment: Drug: Baclofen

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Eating Disorders Clinic, New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Additional exclusion criteria for people with BN:

• Underweight (BMI less than 18 kg/m²)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of binge eating	Measured at Week 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Cravings associated with binge eating	Measured at Week 13

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (ACTUAL): June 1, 2006
• Study Completion (ACTUAL): June 1, 2007

Study Registration Dates

• First Submitted: April 28, 2006
• First Submitted That Met QC Criteria: April 28, 2006
• First Posted (ESTIMATE): April 27, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): August 12, 2013
• Last Update Submitted That Met QC Criteria: August 8, 2013
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Binge Eating Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Signs and Symptoms, Digestive; Hyperphagia; Disease; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: #5017; DNBBS 72-NBR (DNBBS 72-NBR); R21MH065024 (NIH)