Drug and Alcohol Dependence 2017;177:249-257. [doi: 10.1016/j.drugalcdep.2017.04.020]
Kevin M. Gray, MD (Medical University of South Carolina, SC Node), Susan C. Sonne, PharmD (Medical University of South Carolina, SC Node), Erin A. McClure, PhD (Medical University of South Carolina, SC Node), Udi E. Ghitza, PhD (NIDA Center for the Clinical Trials Network [CCTN]), Abigail G. Matthews, PhD (Emmes Corporation), Aimee L. McRae-Clark, PharmD (Medical University of South Carolina, SC Node), Kathleen M. Carroll, PhD (Yale University, NEC Node), Jennifer Sharpe Potter, PhD, MPH (University of Texas San Antonio, TX Node), Katharina Wiest, PhD (CODA, Inc., WS Node), Larissa J. Mooney, MD (UCLA, PR Node), Albert Hasson, MSW (UCLA, PR Node), Sharon L. Walsh, PhD (University of Kentucky, OV Node), Michelle R. Lofwall, MD (University of Kentucky, OV Node), Shanna Babalonis, PhD (University of Kentucky, OV Node), Robert W. Lindblad, MD (Emmes Corporation), Steven Sparenborg, PhD (NIDA CCTN), Aimee Wahle (Emmes Corporation), Jacqueline S. King, MS (Emmes Corporation), Nathaniel L. Baker, MS (Medical University of South Carolina, SC Node), Rachel L. Tomko, MD (Medical University of South Carolina, SC Node), Louise F. Haynes, MSW (Medical University of South Carolina, SC Node), Ryan G. Vandrey, PhD (Johns Hopkins University, MA Node), Frances R. Levin, MD (Columbia University, GNY Node).
This is the Primary Outcomes Article for CTN-0053. Cannabis use disorder (CUD) is a prevalent and impairing condition, and established psychosocial treatments convey limited efficacy. In light of recent findings supporting the efficacy of N-acetylcysteine (NAC) for CUD in adolescents, the objective of this trial was to evaluate its efficacy in adults. In a 12-week double-blind randomized placebo-controlled trial, treatment-seeking adults ages 18-50 with CUD (N=302), enrolled across six NIDA Clinical Trials Network-affiliated clinical sites, were randomized in a 1:1 ratio to a 12-week course of NAC 1200 mg (n=153) or placebo (n=149) twice daily. All participants received contingency management (CM) and medical management. The primary efficacy measure was the odds of negative urine cannabinoid tests during treatment, compared between NAC and placebo participants.
Results found not-statistically-significant evidence that the NAC and placebo groups differed in cannabis abstinence (odds ratio=1.00, 95% confidence interval 0.63-1.59; p=0.984). Overall, 22.3% of urine cannabinoid tests in the NAC group were negative, compared with 22.4% in the placebo group. Many participants were medication non-adherent; however, exploratory analysis within the medication-adherent subgroups revealed no significant differential abstinence outcomes by treatment group.
Conclusions: In contrast with significant prior findings in adolescents, there is no evidence that NAC 1200mg twice daily plus CM is differentially efficacious for CUD in adults when compared to placebo plus CM. This discrepant finding between adolescents and adults with CUD may have been influenced by differences in development, cannabis use profiles, responses to embedded behavioral treatment, medication adherence, and other factors. In light of these findings, a replication trial of NAC in adolescents with CUD is indicated. (Article (Peer-Reviewed), PDF, English, 2017)
Keywords: Cannabis use disorder | Contingency management | CTN primary outcomes | N-acetylcysteine | Marijuana | Pharmacological therapy | Drug and Alcohol Dependence (journal)
Document No: 1270.
Submitted by Jack Blaine, MD, NIDA Center for the Clinical Trials Network, 6/13/2017.