Transdermal Nicotine and Haloperidol in Tourette's Disorder: A Double-Blind Placebo-Controlled Study
J Clin Psychiatry 2001;62(9):707-714
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Background: Preclinical animal and open-trial
clinical trials using nicotine gum and the transdermal nicotine
patch found that treatment with nicotine potentiates the effects
of neuroleptics in reducing the dyskinetic symptoms of Tourette's
disorder. We sought to verify and expand these findings in a
prospective double-blind placebo-controlled trial.
Method: Seventy patients with DSM-IV Tourette's
disorder were treated with either transdermal nicotine (7 mg/24
hours) or placebo patches in a 33-day, randomized, double-blind
study. Each patient received an individually based optimal dose
of haloperidol for at least 2 weeks prior to random assignment to
nicotine or placebo treatment. A new patch was worn each day for
the first 5 days. On the sixth day, the dose of haloperidol was
reduced by 50%. Daily patch applications were then continued for
an additional 2 weeks (through day 19), at which time the patch
was discontinued, but the 50% dose of haloperidol was continued
for an additional 2 weeks (through day 33). Clinical and safety
assessments were made at each visit.
Results: Patients who completed all 19 days of
nicotine (N = 27) or placebo (N = 29) patch treatment were used
in efficacy analyses. As documented by the Clinician- and
Parent-rated Global Improvement scales, transdermal nicotine was
superior to placebo in reducing the symptoms of Tourette's
disorder. The Yale Global Tic Severity Scale was less sensitive
in detecting a placebo/drug difference than were the global
improvement scores, suggesting that some of the improvement may
not have been related to treatment-related changes in tic
severity, but to the emotional and behavioral symptoms. The side
effects of nausea and vomiting were significantly more common in
the nicotine group (71% [N = 25] and 40% [N = 14]) than in the
placebo group (17% [N = 6] and 9% [N = 3]) (nausea, p = .0001;
vomiting, p = .004).
Conclusion: Transdermal nicotine was superior to
placebo in reducing behavioral symptoms when patients were
receiving an optimal dose of haloperidol, when the dose of
haloperidol was reduced by 50%, and when the patch had been
discontinued for 2 weeks. These findings confirm earlier
open-label findings and suggest that combining nicotinic receptor
modulation and neuroleptics could be a therapeutic option for the
treatment of Tourette's disorder. While side effects limit
chronic use of nicotine, it may be useful on a p.r.n. basis.
Further clinical research is warranted to investigate the use of
novel nicotinic receptor modulating agents with improved safety
profiles over nicotine.