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Published Online: 1 August 2012

A Double-Blind Randomized Controlled Trial of N-Acetylcysteine in Cannabis-Dependent Adolescents

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Kevin M. Gray, M.D., Matthew J. Carpenter, Ph.D., Nathaniel L. Baker, M.S., Stacia M. DeSantis, Ph.D., Elisabeth Kryway, P.A.-C., Karen J. Hartwell, M.D., Aimee L. McRae-Clark, Pharm.D., and Kathleen T. Brady, M.D., Ph.D.Authors Info & Affiliations

Publication: American Journal of Psychiatry

Volume 169, Number 8

https://doi.org/10.1176/appi.ajp.2012.12010055

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Abstract

N-acetylcysteine (1,200 mg twice a day) was added to contingency management intervention and very brief weekly cessation counseling in an 8-week, double-blind, randomized, placebo-controlled trial for treatment-seeking cannabis-dependent adolescents. The rate of negative urine cannabinoid tests was 41% in the N-acetylcysteine group, compared to 27% for the placebo group. At the posttreatment follow-up visit, 19% of the urine tests in the N-acetylcysteine group were negative, compared to 10% in the placebo group. Adverse events were not common and included vivid dreams and heartburn.

Abstract

Objective:

Preclinical findings suggest that the over-the-counter supplement N-acetylcysteine (NAC), via glutamate modulation in the nucleus accumbens, holds promise as a pharmacotherapy for substance dependence. The authors investigated NAC as a novel cannabis cessation treatment in adolescents, a vulnerable group for whom existing treatments have shown limited efficacy.

Method:

In an 8-week double-blind randomized placebo-controlled trial, treatment-seeking cannabis-dependent adolescents (ages 15–21 years; N=116) received NAC (1200 mg) or placebo twice daily as well as a contingency management intervention and brief (<10 minutes) weekly cessation counseling. The primary efficacy measure was the odds of negative weekly urine cannabinoid test results during treatment among participants receiving NAC compared with those receiving placebo, in an intent-to-treat analysis. The primary tolerability measure was frequency of adverse events, compared by treatment group.

Results:

Participants receiving NAC had more than twice the odds, compared with those receiving placebo, of having negative urine cannabinoid test results during treatment (odds ratio=2.4, 95% CI=1.1–5.2). Exploratory secondary abstinence outcomes favored NAC but were not statistically significant. NAC was well tolerated, with minimal adverse events.

Conclusions:

This is the first randomized controlled trial of pharmacotherapy for cannabis dependence in any age group to yield a positive primary cessation outcome in an intent-to-treat analysis. Findings support NAC as a pharmacotherapy to complement psychosocial treatment for cannabis dependence in adolescents.

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Information & Authors

Information

Published In

American Journal of Psychiatry

Volume 169 • Number 8 • August 2012

Pages: 805 - 812

PubMed: 22706327

History

Received: 13 January 2012

Revision received: 7 March 2012

Revision received: 3 April 2012

Accepted: 6 April 2012

Published online: 1 August 2012

Published in print: August 2012

Authors

Details

Kevin M. Gray, M.D.

From the Department of Psychiatry and Behavioral Sciences, the Hollings Cancer Center, and the Division of Biostatistics and Epidemiology, Department of Medicine, Medical University of South Carolina, Charleston; and the Ralph H. Johnson Veterans Affairs Medical Center, Charleston.

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Matthew J. Carpenter, Ph.D.

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Nathaniel L. Baker, M.S.

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Stacia M. DeSantis, Ph.D.

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Elisabeth Kryway, P.A.-C.

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Karen J. Hartwell, M.D.

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Aimee L. McRae-Clark, Pharm.D.

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Kathleen T. Brady, M.D., Ph.D.

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Notes

Address correspondence to Dr. Gray ([email protected]).

Funding Information

Dr. Gray has received research funding from Merck and Supernus Pharmaceuticals. Dr. Hartwell has received research funding from Pfizer. Dr. McRae-Clark has received research funding from Shire Pharmaceuticals. Dr. Brady has received research funding from GlaxoSmithKline. The other authors report no financial relationships with commercial interests.Supported by National Institute on Drug Abuse (NIDA) grant R01DA026777, via the American Recovery and Reinvestment Act of 2009. Administrative and technical support was provided by National Center for Research Resources grant UL1RR029882. Dr. Carpenter's effort was supported by NIDA grant K23DA020482.

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A Double-Blind Randomized Controlled Trial of N-Acetylcysteine in Cannabis-Dependent Adolescents

Abstract