Acamprosate in the Treatment of Binge-Eating Disorder

June 21, 2011 updated by: Lindner Center of HOPE
The purpose of this research study is to determine the efficacy (how well it works), tolerability and safety of acomprosate compared with placebo in patients with binge eating disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Mason, Ohio, United States, 45040
        • Lindner Center of Hope

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects will meet the DSM-IV (1) criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV criteria are as follows:

    • Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions; and a sense of lack of control over eating during the episode (eg, a feeling that one cannot stop eating or control what or how much one is eating).
    • The binge eating episodes are associated with at least three of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating.
    • Marked distress regarding binge eating.
    • The binge eating occurs, on average, at least two days a week for six months.
    • The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
  • In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization
  • Weight > 85% of the midpoint of ideal body weight for their height. (According to the Metropolitan Height/Weight table.) The subject population is expected to include both normal weight and obese individuals (although the majority of subjects are expected to be overweight).
  • Men or women, between the ages of 18 and 65. The subject population is expected to be predominantly made up of women.

Exclusion Criteria:

  • Have concurrent symptoms of bulimia nervosa or anorexia nervosa, including weight loss to at least 15% below the Metropolitan Height/Weight tables.
  • Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study).
  • Patients who are displaying clinically significant suicidality or homicidality.
  • Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for BED for at least 3 months prior to randomization.
  • A DSM-IV diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
  • A lifetime DSM-IV history of psychosis, mania or hypomania, or dementia.
  • History of any psychiatric and personality disorder (eg, schizotypal and borderline) which might interfere with a diagnostic assessment, treatment, or compliance.
  • Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, treatment, or assessment of BED. Patients should be biochemically euthyroid to enter the study.
  • History of seizures, including febrile seizures in childhood.
  • Patients requiring treatment with any drug which might interact adversely with or obscure the action of the study medication.
  • Clinically relevant abnormal laboratory results, specifically including hypokalemia.
  • Patients who have received monoamine oxidase inhibitors, antipsychotics, lithium, or fluoxetine within four weeks prior to randomization.
  • Patients who have received other psychoactive medications (other than hypnotics) within one week prior to randomization.
  • Patients who have received investigational medications or depot neuroleptics within three months prior to randomization.
  • Patients previously enrolled in this study or have previously been treated with acamprosate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
sugar pill
Other: placebo
oral, placebo
Experimental: 1
acamprosate
Drug: acamprosate
999 mg/day - 2997 mg/day, oral
Other Names:
  • Campral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy variable will be change in weekly binge frequency
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary efficacy variables will include change in binge day frequency (days during which at least one binge occurs), obsessive-compulsive symptoms of BED, craving for food, depressive symptoms, weight, and BMI
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lindner Center of HOPE

Collaborators

Forest Laboratories
University of Cincinnati

Investigators

  • Principal Investigator: Susan L McElroy, MD, Lindner Center of Hope

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (Estimate)

August 6, 2007

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMP-MD-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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