Status:
COMPLETED
N-Acetylcysteine and Smoking Reduction
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Nicotine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
N-acetylcysteine is an inexpensive agent with a benign side effect profile with preliminary studies in humans suggesting efficacy for the treatment of cocaine dependence. N-acetylcysteine has been use...
Eligibility Criteria
Inclusion
- Be smokers motivated to reduce their cigarette usage but not seeking treatment to quit smoking at the time of screening.
- Be Able to give written informed consent after being presented with an IRB-approved informed consent document
- Be male or female of any race, between eighteen and sixty five years of age.
- Be in stable physical and mental health as judged by interview
- Be smoking 10 or more cigarettes per day for one or more years
- Have an expired CO reading of ≥10 parts/million prior to beginning study
- Test non-pregnant and use adequate birth control (female only). All female subjects will have a urine pregnancy test performed prior to the first dose of study medication.
- Be able to comply with protocol requirements and be likely to complete all study treatments.
- Live within 50 miles of the study site
Exclusion
- Have current dependence, defined by DSM IV criteria, on any psychoactive substance other than nicotine, alcohol, or marijuana or physiological dependence on alcohol requiring medical detoxification.
- Have a history of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic or metabolic disorders.
- Have a history of adverse reaction/hypersensitivity to N-acetylcysteine.
- Have any significant active medical or psychiatric illness (e.g. schizophrenia, suicidal/homicidal ideation within the past 30 days) which might inhibit their ability to complete the study or might be complicated by administration of NAC.
- Used carbamazepine or Nitroglycerin within the last 14 days or any other medication felt to be hazardous if taken with NAC
- Have a current or past history of asthma and/or the occasional or daily use of Albuterol or other beta-agonist inhalers.
- Females pregnant or breast-feeding
- Have any medical history or condition considered by the investigator(s) to place the subjects at increased risk.
- Not fail to actively meet the inclusion criteria at the time of screening.
- Have a history of childhood or adult seizures of any cause.
- Be currently taking any medications (i.e., beta-blockers, stimulant medications) that might affect heart rate or skin conductance
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00751257
Start Date
December 1 2006
End Date
October 1 2007
Last Update
March 23 2017
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425