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Achieving Cannabis Cessation -- Evaluating N-Acetylcysteine Treatment (ACCENT): Design and Implementation of a Multi-Site, Randomized Controlled Study in the National Institute on Drug Abuse Clinical Trials Network.

Contemporary Clinical Trials 2014;39(2):211-223. [doi: 10.1016/j.cct.2014.08.011]

Erin A. McClure, PhD (Medical University of South Carolina, SC Node), Susan C. Sonne, PharmD (Medical University of South Carolina, SC Node), Theresa M. Winhusen, PhD (University of Cincinnati, OV Node), Kathleen M. Carroll, PhD (Yale University School of Medicine, NEC Node), Udi E. Ghitza, PhD (Center for the Clinical Trials Network, NIDA), Aimee L. McRae-Clark, PharmD (Medical University of South Carolina, SC Node), Abigail G. Matthews, PhD (EMMES Corporation, Data & Statistics Center), Gaurav Sharma, PhD (EMMES Corporation, Data & Statistics Center), Paul C. VanVeldhuisen, PhD (EMMES Corporation, Data & Statistics Center), Ryan G. Vandrey, PhD (Johns Hopkins University School of Medicine), Frances R. Levin, MD (New York State Psychiatric Institute, GNY Node), Roger D. Weiss, MD (Harvard University, McLean Hospital, NEC Node), Robert Lindblad, MD (EMMES Corporation, Data & Statistics Center), Colleen Allen, MPH (EMMES Corporation, Data & Statistics Center), Larissa J. Mooney, MD (University of California, Los Angeles, PR Node), Louise F. Haynes, MSW (Medical University of South Carolina, SC Node), Gregory S. Brigham, PhD (Maryhaven, Inc., OV Node), Steven Sparenborg, PhD (Center for the Clinical Trials Network, NIDA), Albert L. Hasson, MSW (University of California, Los Angeles, PR Node), Kevin M. Gray, MD (Medical University of South Carolina, SC Node).

Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Drug Abuse Treatment Clinical Trials Network (CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PB), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PB. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. The results from this study have the potential to improve treatment and have a marked impact on clinical practice and public health. (Article (Peer-Reviewed), PDF, English, 2014)

Keywords: Behavior therapy | Marijuana | Motivational incentives | N-acetylcysteine | Pharmacological therapy | Contemporary Clinical Trials (journal)

Document No: 1097, PMID: 25179587, PMCID: PMC4252394.

Submitted by CTN Dissemination Librarians, 9/4/2014.

AUTHORS SEARCH LINK
Allen, Colleen mail
Brigham, Gregory S. mail
Carroll, Kathleen M. mail
Ghitza, Udi E. mail
Gray, Kevin M. mail
Hasson, Albert L. mail
Haynes, Louise F. mail
Levin, Frances R. mail
Lindblad, Robert mail
Matthews, Abigail G. mail
McClure, Erin A. mail
McRae-Clark, Aimee L. mail
Mooney, Larissa J. mail
Sharma, Guarav mail
Sonne, Susan C. mail
Sparenborg, Steven mail
Vandrey, Ryan G.
VanVeldhuisen, Paul C. mail
Weiss, Roger D. mail
Winhusen, Theresa M. mail
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