TY - JOUR
T1 - Achieving cannabis cessation - Evaluating N-acetylcysteine treatment (ACCENT)
T2 - Design and implementation of a multi-site, randomized controlled study in the national institute on drug abuse clinical trials network
AU - McClure, Erin A.
AU - Sonne, Susan C.
AU - Winhusen, Theresa
AU - Carroll, Kathleen M.
AU - Ghitza, Udi E.
AU - McRae-Clark, Aimee L.
AU - Matthews, Abigail G.
AU - Sharma, Gaurav
AU - Van Veldhuisen, Paul
AU - Vandrey, Ryan G.
AU - Levin, Frances R.
AU - Weiss, Roger D.
AU - Lindblad, Robert
AU - Allen, Colleen
AU - Mooney, Larissa J.
AU - Haynes, Louise
AU - Brigham, Gregory S.
AU - Sparenborg, Steve
AU - Hasson, Albert L.
AU - Gray, Kevin M.
N1 - Funding Information:
This work was supported by the National Institute on Drug Abuse National Drug Clinical Trials Network Grants U10DA013727 (Kathleen T. Brady), U10DA15831 (Kathleen M. Carroll and Roger D. Weiss), NIDA K24DA022288 (Roger D. Weiss), U10DA013045 (Walter Ling), U10DA013034 (Maxine L. Stitzer and Robert P. Schwartz), U10DA013732 (Theresa Winhusen), U10DA013714 (James L. Sorensen and Dennis McCarty); and NIDA Contracts N01DA92217 and N01DA102221 (The EMMES Corporation). The authors would like to thank the staff at the study sites and the regional research and training programs of the NIDA CTN who participated in the development and implementation of this study. Special thanks to Ashley Morrill, Ricardo Cantu, Sarah Brewer, and Christine Horne for their hard work and dedication to the implementation of the ACCENT study. The opinions in this manuscript are those of the authors and do not represent the official position of the U.S. government.
Publisher Copyright:
© 2014 Elsevier Inc.
PY - 2014/11/1
Y1 - 2014/11/1
N2 - 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 Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), 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 PBO. 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 (1200. mg) 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.
AB - 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 Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), 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 PBO. 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 (1200. mg) 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.
KW - Cannabis
KW - Clinical study design
KW - Marijuana
KW - N-acetylcysteine
KW - Pharmacotherapy
KW - Randomized trials
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U2 - 10.1016/j.cct.2014.08.011
DO - 10.1016/j.cct.2014.08.011
M3 - Article
C2 - 25179587
AN - SCOPUS:84908574915
SN - 1551-7144
VL - 39
SP - 211
EP - 223
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 2
ER -