N-acetylcysteine in the Treatment of Bulimia Nervosa

This study has been terminated.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT01033149
First received: December 14, 2009
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Bulimia Nervosa
Drug: N-acetylcysteine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • The primary outcome measure will be the weekly frequency of binge-purge episodes. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: December 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
N-acetylcysteine
open label N-acetylcysteine, flexible dose
Drug: N-acetylcysteine
N-acetylcysteine, flexible dose 1200-2400mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033149

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

Publications:
Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01033149     History of Changes
Other Study ID Numbers: 19223, 09-09-18-01, NAC in Bulimia Nervosa
Study First Received: December 14, 2009
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Eating Disorders
Hyperphagia
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014