- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218491
Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1 (NAC)
A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1200mg N-Acetylcysteine
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1200mg N-Acetylcysteine
2400mg N-Acetylcysteine
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Experimental: 2400mg N-Acetylcysteine
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1200mg N-Acetylcysteine
2400mg N-Acetylcysteine
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Placebo Comparator: Matching Placebo
|
Matching Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants That Achieved Study Compliance
Time Frame: 8 weeks
|
Drug and placebo compliance were measured by urine riboflavin levels.
Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml
|
8 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Malcolm, M.D., Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- NIDA-19903-1
- DPMC (Other Identifier: NIDA)
- R01DA019903 (U.S. NIH Grant/Contract)
- R01-19903-1
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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