Erin A McClure1, Amy E Wahlquist2, Rachel L Tomko3, Nathaniel L Baker4, Matthew J Carpenter5, Elizabeth D Bradley3, Patrick A Cato3, Cassandra D Gipson6, Kevin M Gray3. 1. Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, 67 President St., MSC 861, Charleston, SC, 29425, USA; Hollings Cancer Center, Medical University of South Carolina, 86 Jonathan Lucas St., Charleston, SC, 29425, USA. Electronic address: mccluree@musc.edu. 2. East Tennessee State University, Center for Rural Health Research, Department of Biostatistics and Epidemiology, 104 Lamb Hall, Johnson City, TN, 37612, USA. 3. Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, 67 President St., MSC 861, Charleston, SC, 29425, USA. 4. Medical University of South Carolina, Department of Public Health Sciences, 135 Cannon St., Charleston, SC, 29425, USA. 5. Medical University of South Carolina, Department of Psychiatry and Behavioral Sciences, 67 President St., MSC 861, Charleston, SC, 29425, USA; Hollings Cancer Center, Medical University of South Carolina, 86 Jonathan Lucas St., Charleston, SC, 29425, USA. 6. Department of Family and Community Medicine, University of Kentucky, 2195 Harrodsburg Rd., Lexington, KY, 40504, USA.
Abstract
BACKGROUND: There is robust preclinical literature and preliminary clinical findings supporting the use of N-Acetylcysteine (NAC) to treat substance use disorders, including tobacco use disorder (TUD). However, randomized controlled trials have yielded mixed results and NAC's efficacy for TUD has not been established. The goals of this study were to assess the efficacy of NAC in promoting early and end-of-treatment abstinence and preventing relapse among adult smokers. METHODS: This randomized, double-blinded clinical trial enrolled adult, daily smokers (N = 114; ages 23-64; 51 % female; 65 % White; 29 % Black/African American; 7% Hispanic/Latinx), who were randomized 1:1 to receive NAC (n = 59) or placebo (n = 55) (1200 mg b.i.d.) for eight weeks. Participants received brief cessation counseling and incentives for abstinence during the first three days of the quit attempt. Primary outcomes: (i) carbon monoxide (CO)-confirmed abstinence during the first three days of the quit attempt. SECONDARY OUTCOMES: (ii) time to relapse; (iii) biologically confirmed abstinence at Week 8. RESULTS: No differences were found between NAC and placebo groups on measures of early abstinence (3-day quit attempt; 11 % for NAC vs. 15 % for placebo; all p > 0.11), time to relapse (p = 0.19), and end-of-treatment abstinence (7% for NAC vs. 11 % for placebo; all p > 0.40]. CONCLUSIONS: Results indicate that NAC is a well-tolerated pharmacotherapy but is unlikely to be efficacious as a monotherapy for TUD in adults. Considered in the collective context of other research, NAC may potentially be more useful in a younger population, as a combination pharmacotherapy, or in the presence of more intensive psychosocial treatment.
BACKGROUND: There is robust preclinical literature and preliminary clinical findings supporting the use of N-Acetylcysteine (NAC) to treat substance use disorders, including tobacco use disorder (TUD). However, randomized controlled trials have yielded mixed results and NAC's efficacy for TUD has not been established. The goals of this study were to assess the efficacy of NAC in promoting early and end-of-treatment abstinence and preventing relapse among adult smokers. METHODS: This randomized, double-blinded clinical trial enrolled adult, daily smokers (N = 114; ages 23-64; 51 % female; 65 % White; 29 % Black/African American; 7% Hispanic/Latinx), who were randomized 1:1 to receive NAC (n = 59) or placebo (n = 55) (1200 mg b.i.d.) for eight weeks. Participants received brief cessation counseling and incentives for abstinence during the first three days of the quit attempt. Primary outcomes: (i) carbon monoxide (CO)-confirmed abstinence during the first three days of the quit attempt. SECONDARY OUTCOMES: (ii) time to relapse; (iii) biologically confirmed abstinence at Week 8. RESULTS: No differences were found between NAC and placebo groups on measures of early abstinence (3-day quit attempt; 11 % for NAC vs. 15 % for placebo; all p > 0.11), time to relapse (p = 0.19), and end-of-treatment abstinence (7% for NAC vs. 11 % for placebo; all p > 0.40]. CONCLUSIONS: Results indicate that NAC is a well-tolerated pharmacotherapy but is unlikely to be efficacious as a monotherapy for TUD in adults. Considered in the collective context of other research, NAC may potentially be more useful in a younger population, as a combination pharmacotherapy, or in the presence of more intensive psychosocial treatment.
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