N-Acetylcysteine and Smoking Reduction
Information source: Medical University of South Carolina
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nicotine Dependence
Intervention: N-acetylcysteine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Medical University of South Carolina
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 used in clinical medicine for nearly three decades to treat
chronic lung conditions, acetaminophen overdose, and experimentally to treat cocaine
dependence. It is generally safe and well tolerated. The present pilot study seeks to
explore safety and tolerability, ad lib smoking, visual cue reactivity, and smoking
reduction rates in a group of nontreatment seeking, nicotine dependence smokers who are
willing to undergo a brief trial with oral N-acetylcysteine 1200 mg twice daily.
Clinical Details
Official title: A Randomized Controlled Trial of Oral N-acetylcysteine for Smoking Reduction: a Pilot Study
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Carbon Monoxide LevelsSmoking Level Craving Levels (Questionnaire for Smoking Urges -- Brief) Minnesota Nicotine Withdrawal Scale (MNWS)
Secondary outcome: Smoking Level
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Be smokers motivated to reduce their cigarette usage but not seeking treatment to
quit smoking at the time of screening.
2. Be Able to give written informed consent after being presented with an IRB-approved
informed consent document
3. Be male or female of any race, between eighteen and sixty five years of age.
4. Be in stable physical and mental health as judged by interview
5. Be smoking 10 or more cigarettes per day for one or more years
6. Have an expired CO reading of ≥10 parts/million prior to beginning study
7. 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.
8. Be able to comply with protocol requirements and be likely to complete all study
treatments.
9. Live within 50 miles of the study site
Exclusion Criteria:
1. 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.
2. 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.
3. Have a history of adverse reaction/hypersensitivity to N-acetylcysteine.
4. 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.
5. Used carbamazepine or Nitroglycerin within the last 14 days or any other medication
felt to be hazardous if taken with NAC
6. Have a current or past history of asthma and/or the occasional or daily use of
Albuterol or other beta-agonist inhalers.
7. Females pregnant or breast-feeding
8. Have any medical history or condition considered by the investigator(s) to place the
subjects at increased risk.
9. Not fail to actively meet the inclusion criteria at the time of screening.
10. Have a history of childhood or adult seizures of any cause.
11. Be currently taking any medications (i. e., beta-blockers, stimulant medications) that
might affect heart rate or skin conductance
Locations and Contacts
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Additional Information
Starting date: December 2006
Last updated: September 11, 2012
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