Methylphenidate for treating tobacco dependence in non-attention deficit hyperactivity disorder smokers: A pilot randomized placebo-controlled trialReportar como inadecuado




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Journal of Negative Results in BioMedicine

, 10:1

Overcoming Publication Bias in Clinical Trials

Abstract

BackgroundMethylphenidate blocks the re-uptake of dopamine by binding to the dopamine transporter in the presynaptic cell membrane and increases extracellular dopamine levels. Similarities in neuropsychologic effects between nicotine and methylphenidate make it an intriguing potential therapeutic option. Previous research of methylphenidate in smokers has suggested a possible beneficial effect for the relief of nicotine withdrawal symptoms, but showed no efficacy in helping smokers with attention deficit hyperactivity disorder ADHD to stop smoking.

MethodsTo investigate potential efficacy for relieving nicotine withdrawal symptoms and promoting smoking abstinence, we conducted a randomized, double-blind, placebo-controlled, phase II study of once-a-day osmotic-release oral system methylphenidate OROS-MPH, Concerta at a target dose of 54-mg-day for 8 weeks compared with placebo in 80 adult cigarette smokers.

ResultsOf the 80 randomized subjects and median smoking rate was 20 cigarettes per day. At the end of the medication phase, the biochemically confirmed 7-day point prevalence smoking abstinence was 10% 4-40 for the placebo group and 2.5% 1-40 for the OROS-MPH group.

Nicotine withdrawal was not found to differ significantly between treatment groups during the first 14 days following the start of medication prior to the target quit date p = 0.464 or during the first 14 days following the target quit date p = 0.786.

ConclusionWe observed no evidence of efficacy of OROS-MPH to aid smokers to stop smoking. Although there are biologically plausible hypotheses that support the use of OROS-MPH for treating tobacco dependence, we found no evidence to support such hypotheses. In addition to no increase in smoking abstinence, we saw no effect of OROS-MPH for tobacco withdrawal symptom relief and no change in smoking rates was observed in the OROS-MPH group compared to the placebo group.

Electronic supplementary materialThe online version of this article doi:10.1186-1477-5751-10-1 contains supplementary material, which is available to authorized users.

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Autor: Richard D Hurt - Jon O Ebbert - Ivana T Croghan - Darrell R Schroeder - Amit Sood - J Taylor Hays

Fuente: https://link.springer.com/







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