This phase II trial studies how well acetylcysteine works in preventing tobacco use in participants who are daily smokers or nicotine dependent. Nutritional supplements and antioxidants, such as acetylcysteine, may help participants who are daily smokers or nicotine dependent quit smoking or prevent relapse (return of tobacco use).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02737358.
PRIMARY OBJECTIVES:
I. Examine the efficacy of acetylcysteine (N-acetylcysteine [NAC]), compared to placebo, in helping smokers achieve three days of continuous abstinence.
II. Among those who maintain initial 3-day abstinence, examine the time to relapse over the 8-week intervention between NAC and placebo groups.
III. Assess 7-day point prevalence abstinence at the 8-week end-of-treatment study visit in order to obtain effect sizes and estimates of variability to power a randomized clinical trial.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive acetylcysteine orally (PO) twice daily (BID) and tobacco cessation counseling for 8 weeks.
GROUP II: Participants receive matched placebo PO BID and tobacco cessation counseling for 8 weeks.
After completion of study treatment, participants are followed up at 4 weeks.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorErin A. McClure
