N-acetylcysteine in the Treatment of Bulimia Nervosa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01033149
Recruitment Status : Terminated
First Posted : December 16, 2009
Last Update Posted : March 5, 2014
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

Brief Summary:
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of N-acetylcysteine (NAC) in the treatment on bulimia nervosa.

Condition or disease Intervention/treatment Phase
Bulimia Nervosa Drug: N-acetylcysteine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
open label N-acetylcysteine, flexible dose
Drug: N-acetylcysteine
N-acetylcysteine, flexible dose 1200-2400mg/day

Primary Outcome Measures :
  1. The primary outcome measure will be the weekly frequency of binge-purge episodes. [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men or women, between the ages of 18 and 65. The patient population is expected to be predominantly made up of women based on previous research.
  2. Patients will meet DSM-IV-TR criteria for BN for at least the last 6 months. These criteria are as follows:

    A. Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following:

    1. Eating, in a fixed period of time, an amount of food that is definitely larger than most people would eat under similar circumstances.
    2. A sense of lack of control over eating during the episode B. Recurrent inappropriate compensatory behavior to prevent weight gain, such as: self-induced vomiting; misuse of laxatives; diuretics; or other medications; fasting; excessive exercise.

    C. Binge-purge episodes occur at least two times a week in the last 3 months D. Self- evaluation in unduly influenced by body shape and weight E. The disturbance does not occur exclusively during episodes of anorexia nervosa.

  3. Capacity to consent to the study and comply with study procedures.

Exclusion Criteria:

Criteria for exclusion from this study will be any of the following:

  1. Have current body mass index (BMI) < 20kg/m2.
  2. Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures.
  3. Subjects who are displaying clinically significant suicidality or homicidality.
  4. A current or recent (within 6 months of the start of NAC) DSM-IV-TR diagnosis of substance abuse or dependence.
  5. History of a personality disorder (eg, schizotypal, borderline, or antisocial) which might interfere with assessment or compliance with study procedures
  6. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, assessment, or treatment of BN. Patients should be biochemically euthyroid prior to entering the study.
  7. DSM-IV-TR Anorexia nervosa
  8. Serum potassium of ≤ 0.3mmol/L
  9. Myocardial infarction within six months
  10. Subjects taking more than 200 /µg of selenium per day, or 500 IU of Vitamin E /day
  11. Subjects with known or suspected clinically relevant systemic medical disorder, including asthma, bronchospasm, or respiratory insufficiency.
  12. Subjects who had recently used medications (<14 days) felt to be hazardous if taken with NAC (e.g. carbamazepine, nitroglycerin).
  13. Subjects previously enrolled in this study; subjects who have previously been treated with NAC; subjects who have received an experimental drug or have used an experimental device within 30 days.

Subjects who are taking psychotropic medications will be allowed into the study as long as the dose of medication had been stable for 3 months before study inclusion and there are no plans to modify the dose during the study duration. Similarly, subjects evolved in psychotherapy for BN will be allowed to participate if attendance had been ongoing for at least 3 months before study entry. Subjects who changed doses of medication or started new therapy will be discontinued from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01033149

United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati

Publications of Results:
Responsible Party: Lindner Center of HOPE Identifier: NCT01033149     History of Changes
Other Study ID Numbers: 19223, 09-09-18-01
NAC in Bulimia Nervosa
First Posted: December 16, 2009    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Bulimia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs