Status:
COMPLETED
Effectiveness of N-acetylcysteine in Treating Cocaine Dependent Individuals - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine-Related Disorders
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to determine the safety,...
Detailed Description
Recent findings have suggested that N-acetylcysteine (NAC) substantially reduces cocaine-primed drug-seeking behavior in formerly cocaine dependent rats. The purpose of this study is to determine the ...
Eligibility Criteria
Inclusion
- Not seeking treatment for drugs of abuse
- Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis of cocaine dependence (not applicable for individuals enrolling as healthy controls)
- Positive urine drug screen test for cocaine (not applicable for individuals enrolling as healthy controls)
- Females must use adequate forms of contraception throughout the study
- Stable residence for the 30 days prior to enrollment
- No history of N-acetylcysteine within the 7 days prior to enrollment
- Nicotine smokers staying at the inpatient unit must use the nicotine patch during inpatient stay
Exclusion
- Dependence on any psychoactive substance other than alcohol, nicotine, or marijuana; control subjects cannot be dependent on cocaine
- Need for medication detoxification for alcohol
- History of psychiatric disorders, including depression, bipolar disorder, post traumatic stress disorder, dementia, and organic brain disorder
- Suicidal or homicidal behavior within the 30 days prior to enrollment
- History of psychotic symptoms, including those observed during cocaine use
- History of serious medical illness, including cardiovascular disease, angina, myocardial infarction, liver disease, and kidney disease
- History of neurologic, metabolic, neoplastic, nutritional, inflammatory, or endocrine disorders
- Court requirement to receive treatment
- Expecting elective surgery within the 5 weeks prior to enrollment
- Known hypersensitivity to N-acetylcysteine
- Use of antidepressants (such as selective serotonin reuptake inhibitors or tricyclics), dopamine agonists, or psychotropic medications (such as anticonvulsants, antipsychotics, anxiolytics, or psychostimulants) within the 14 days prior to enrollment
- Pregnant or breastfeeding
- History of asthma
- History of seizures
- Participation in treatment for cocaine abuse within the 30 days prior to enrollment
- Lactose intolerance
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00136825
Start Date
March 1 2003
End Date
September 1 2005
Last Update
January 12 2017
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425