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A double-blind placebo-controlled trial of N-acetylcysteine in the treatment of cocaine dependence.

ABSTRACT: There remains no FDA approved medication for the treatment of cocaine dependence. Preclinical studies and early pilot clinical investigations have suggested that N-acetylcysteine (NAC) may be useful in the treatment of the disorder.The present report assessed the efficacy of NAC in the treatment of cocaine dependence.Cocaine-dependent volunteers (n = 111) were randomized to receive daily doses of 1,200 mg of NAC, 2,400 mg of NAC, or placebo. Participants were followed for 8 weeks (up to three visits weekly). At each of these visits, urine samples were collected, along with self-reports of cocaine use. Urine samples were assessed for quantitative levels of benzoylecognine (ie, cocaine metabolite).Overall, the primary results for the clinical trial were negative. However, when considering only subjects who entered the trial having already achieved abstinence, results favored the 2,400 mg NAC group relative to placebo, with the 2,400 mg group having longer times to relapse and lower craving ratings.While the present trial failed to demonstrate that NAC reduces cocaine use in cocaine-dependent individuals actively using, there was some evidence it prevented return to cocaine use in individuals who had already achieved abstinence from cocaine.N-acetylcysteine may be useful as a relapse prevention agent in abstinent cocaine-dependent individuals.

SUBMITTER: LaRowe SD

PROVIDER: S-EPMC4348575 | biostudies-literature | 2013 Sep-Oct

REPOSITORIES: biostudies-literature

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A double-blind placebo-controlled trial of N-acetylcysteine in the treatment of cocaine dependence.

LaRowe Steven D SD Kalivas Peter W PW Nicholas Joyce S JS Randall Patrick K PK Mardikian Pascale N PN Malcolm Robert J RJ

The American journal on addictions 20130515 5

<h4>Background</h4>There remains no FDA approved medication for the treatment of cocaine dependence. Preclinical studies and early pilot clinical investigations have suggested that N-acetylcysteine (NAC) may be useful in the treatment of the disorder.<h4>Objective</h4>The present report assessed the efficacy of NAC in the treatment of cocaine dependence.<h4>Methods</h4>Cocaine-dependent volunteers (n = 111) were randomized to receive daily doses of 1,200 mg of NAC, 2,400 mg of NAC, or placebo. P ...[more]

PMID: 23952889

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Project description:ContextCocaine dependence, which affects 2.5 million Americans annually, has no US Food and Drug Administration-approved pharmacotherapy.ObjectivesTo evaluate the immunogenicity, safety, and efficacy of a novel cocaine vaccine to treat cocaine dependence.DesignA 24-week, phase 2b, randomized, double-blind, placebo-controlled trial with efficacy assessed during weeks 8 to 20 and follow-up to week 24.SettingCocaine- and opioid-dependent persons recruited from October 2003 to April 2005 from greater New Haven, Connecticut.ParticipantsOne hundred fifteen methadone-maintained subjects (67% male, 87% white, aged 18-46 years) were randomized to vaccine or placebo, and 94 subjects (82%) completed the trial. Most smoked crack cocaine along with using marijuana (18%), alcohol (10%), and nonprescription opioids (44%).InterventionOver 12 weeks, 109 of 115 subjects received 5 vaccinations of placebo or succinylnorcocaine linked to recombinant cholera toxin B-subunit protein. Main Outcome Measure Semiquantitative urinary cocaine metabolite levels measured thrice weekly with a positive cutoff of 300 ng/mL.ResultsThe 21 vaccinated subjects (38%) who attained serum IgG anticocaine antibody levels of 43 microg/mL or higher (ie, high IgG level) had significantly more cocaine-free urine samples than those with levels less than 43 microg/mL (ie, low IgG level) and the placebo-receiving subjects during weeks 9 to 16 (45% vs 35% cocaine-free urine samples, respectively). The proportion of subjects having a 50% reduction in cocaine use was significantly greater in the subjects with a high IgG level than in subjects with a low IgG level (53% of subjects vs 23% of subjects, respectively) (P = .048). The most common adverse effects were injection site induration and tenderness. There were no treatment-related serious adverse events, withdrawals, or deaths.ConclusionsAttaining high (>or=43 microg/mL) IgG anticocaine antibody levels was associated with significantly reduced cocaine use, but only 38% of the vaccinated subjects attained these IgG levels and they had only 2 months of adequate cocaine blockade. Thus, we need improved vaccines and boosters. Trial Registration clinicaltrials.gov Identifier: NCT00142857.

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A double-blind placebo-controlled trial of N-acetylcysteine in the treatment of cocaine dependence.

Publications

A double-blind placebo-controlled trial of N-acetylcysteine in the treatment of cocaine dependence.

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