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Methylphenidate for treating tobacco dependence in non-attention deficit hyperactivity disorder smokers: a pilot randomized placebo-controlled trial.

Hurt RD, Ebbert JO, Croghan IT, Schroeder DR, Sood A, Hays JT - J Negat Results Biomed (2011)

Bottom Line: 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.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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Nicotine Dependence Center, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA. rhurt@mayo.edu

ABSTRACT

Background: Methylphenidate 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.

Methods: To 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.

Results: Of 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).

Conclusion: We 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.

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Related in: MedlinePlus

Composite nicotine withdrawal scones before and after the target quit date.
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Figure 1: Composite nicotine withdrawal scones before and after the target quit date.

Mentions: The composite nicotine withdrawal score change from baseline for the first 28 days following the start of medication was almost identical in the 2 groups. 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). Groups also did not differ significantly for the individual item assessing craving (p = 0.724 and p = 0.350 for days 1-14 and 15-28 following the start of medication). Figure 1 graphically shows the composite nicotine withdrawal score as change from baseline through week four, which was two weeks following target quit date. Individual withdrawal symptoms were analyzed separately and the only significant finding was for restlessness, which was increased in the OROS-MPH subjects compared with placebo subjects (p = 0.01 and p = 0.067 from days 1-14 and 15-28 respectfully). This finding is consistent with the reported adverse events where restlessness was more frequent in the OROS-MPH group.


Methylphenidate for treating tobacco dependence in non-attention deficit hyperactivity disorder smokers: a pilot randomized placebo-controlled trial.

Hurt RD, Ebbert JO, Croghan IT, Schroeder DR, Sood A, Hays JT - J Negat Results Biomed (2011)

Composite nicotine withdrawal scones before and after the target quit date.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3038986&req=5

Figure 1: Composite nicotine withdrawal scones before and after the target quit date.
Mentions: The composite nicotine withdrawal score change from baseline for the first 28 days following the start of medication was almost identical in the 2 groups. 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). Groups also did not differ significantly for the individual item assessing craving (p = 0.724 and p = 0.350 for days 1-14 and 15-28 following the start of medication). Figure 1 graphically shows the composite nicotine withdrawal score as change from baseline through week four, which was two weeks following target quit date. Individual withdrawal symptoms were analyzed separately and the only significant finding was for restlessness, which was increased in the OROS-MPH subjects compared with placebo subjects (p = 0.01 and p = 0.067 from days 1-14 and 15-28 respectfully). This finding is consistent with the reported adverse events where restlessness was more frequent in the OROS-MPH group.

Bottom Line: 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.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).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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Nicotine Dependence Center, Mayo Clinic, 200 1st Street SW, Rochester, MN 55905, USA. rhurt@mayo.edu

ABSTRACT

Background: Methylphenidate 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.

Methods: To 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.

Results: Of 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).

Conclusion: We 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.

Show MeSH
Related in: MedlinePlus