Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: N-Acetylcysteine; N-Acetylcysteine; Matching Placebo
Intervention description: 1200mg N-Acetylcysteine; 2400mg N-Acetylcysteine; Matching Placebo
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cocaine Dependence

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 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.
    

Eligibility 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