Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00218491
First received: September 16, 2005
Last updated: November 7, 2011
Last verified: September 2010
  Purpose

Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized by the body to form cysteine, an active compound that normalizes glutamate levels. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals.


Condition Intervention Phase
Cocaine Dependence
Drug: N-Acetylcysteine
Drug: Matching Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Cue reactivity; measured at baseline and Week 5 [ Time Frame: November 2010 ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: November 2005
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1200mg N-Acetylcysteine
Drug: N-Acetylcysteine
1200mg N-Acetylcysteine
Experimental: 2
2400mg N-Acetylcysteine
Drug: N-Acetylcysteine
2400mg N-Acetylcysteine
Placebo Comparator: 3
Matching Placebo
Drug: Matching Placebo
Matching Placebo

Detailed Description:

Currently, no effective pharmacological treatment exists for cocaine dependence. Long-term use of cocaine disrupts normal glutamate levels. If addicts stop using cocaine, glutamate levels drop, which encourages addicts to continue seeking the drug. NAC is a drug that increases intracellular cysteine levels, which in turn leads to normalization of glutamate levels. Currently, NAC is used for the treatment of cystic fibrosis, heart disease, and acetaminophen overdose. Since NAC has the capability of restoring normal glutamate levels, it holds potential as a treatment for cocaine dependence. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals. In addition, this study will evaluate cocaine craving and withdrawal symptoms in individuals taking NAC.

Participants in this double-blind, placebo-controlled trial will be randomly assigned to receive either NAC or placebo. All participants will undergo an initial evaluation, which will include a physical examination, an electrocardiogram, blood samples, urine tests, and cue reactivity measures. Participants in the NAC group will receive either 600 mg or 1200 mg of NAC, two times each day for 8 weeks. In addition, all participants will receive cognitive behavioral therapy throughout the study on a weekly basis. Cocaine use will be confirmed by a urine drug screen test, three times each week. Participants will be assessed on a number of biomedical and psychosocial variables known to influence cocaine treatment outcomes. After Week 2, participants will repeat the cue reactivity procedures, which will include measuring a participant's craving response when exposed to conditioned reminders of prior cocaine use.

  Eligibility

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

Inclusion Criteria:

  • Meets DSM-IV criteria for cocaine dependence, as determined by a mini-SCID interview
  • Currently dependent on cocaine
  • Seeking treatment for cocaine abuse at the time of study entry
  • Currently uses cocaine by smoking, nasal, or intravenous route of administration.
  • Stable physical and mental health, as judged by an interview and physical examination
  • If female, demonstrates a negative pregnancy test and agrees to use an adequate method of contraception for the duration of the study
  • Lives within a 50 mile radius of the research program center and has reliable transportation

Exclusion Criteria:

  • Meets DSM-IV criteria for dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana
  • Physiological dependence on alcohol, which requires medical detoxification
  • History of significant liver, kidney, endocrine, cardiac (e.g., arrhythmia requiring medication, angina pectoris, myocardial infarction), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders (e.g., homocystinuria)
  • History of an adverse reaction to cocaine, including loss of consciousness, chest pain, psychosis, or seizure
  • History of adverse reaction or hypersensitivity to N-acetyl cystine (NAC), or a similar drug
  • Significant active medical or psychiatric illness that might inhibit the ability to complete the study
  • Active high blood pressure, defined as a mean of three sitting blood pressure readings of 145/95 or higher within a 10-day period
  • History of or current asthma
  • Occasional or daily use of albuterol or other beta-agonist inhalers
  • Use of carbamazepine, phenytoin, nitrous oxide, methotrexate, 6 azauridine triacetate, or nitroglycerin within the 2 weeks prior to study entry
  • Use of very large doses of folate, cyanocobalamine (vitamin B12), or pyridoxine (vitamin B6) as prescribed by a health care professional; individuals taking very large doses of these vitamins on a self-initiated basis may enter the study if they are willing to stop use 14 days prior to study entry and to use a standard generic multiple vitamin instead
  • Pregnant or breastfeeding
  • Required by the court to obtain treatment for cocaine dependence
  • Not seeking treatment for cocaine dependence
  • Anticipating elective surgery or hospitalization within 20 weeks of study entry
  • Failure to have a consistent residence for the 4 weeks prior to study entry
  • History of childhood or adult seizures
  • Participated in cocaine treatment (clinical or research) within 30 days of study entry
  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: NCT00218491

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Robert Malcolm, M.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Robert Malcolm, MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00218491     History of Changes
Other Study ID Numbers: NIDA-19903-1, R01DA019903, R01-19903-1, DPMC
Study First Received: September 16, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on October 19, 2014