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

Sponsors and Collaborators:	National Institute on Drug Abuse (NIDA) Medical University of South Carolina
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218491

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence

Resource links provided by NLM:

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Cue reactivity; measured at baseline and Week 5 [ Time Frame: November 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	282
Study Start Date:	November 2005
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1200mg N-Acetylcysteine	Drug: N-Acetylcysteine 1200mg N-Acetylcysteine
2: Experimental 2400mg N-Acetylcysteine	Drug: N-Acetylcysteine 2400mg N-Acetylcysteine
3: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218491

Contacts

Contact: Kristi Huebner, MPH

(843)792-1901

huebnerk@musc.edu

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kristi Huebner, MPH 843-792-1901 huebnerk@musc.edu

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Medical University of South Carolina

Investigators

Principal Investigator:

Robert Malcolm, M.D.

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Robert Malcolm, MD )
Study ID Numbers:	NIDA-19903-1, R01-19903-1, DPMC
Study First Received:	September 16, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00218491 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Anti-Infective Agents
Antioxidants
Mental Disorders
Expectorants
Substance-Related Disorders

Acetylcysteine
Disorders of Environmental Origin
Cocaine
Antiviral Agents
N-monoacetylcystine

Additional relevant MeSH terms:

Cocaine-Related Disorders
Anti-Infective Agents
Respiratory System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Protective Agents
Antiviral Agents

Pharmacologic Actions
Mental Disorders
Expectorants
Therapeutic Uses
Free Radical Scavengers
Substance-Related Disorders
Acetylcysteine
N-monoacetylcystine
Antidotes

ClinicalTrials.gov processed this record on September 01, 2009