Status:
COMPLETED
Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 fo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00218491
Start Date
November 1 2005
End Date
May 1 2010
Last Update
January 15 2019
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425