Smoking Cessation Clinical Trial
Official title:
Pilot Randomized Double Blind, Placebo Controlled Trial of the Efficacy of Simvastatin for Smoking Cessation
Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately,
there are few smoking cessation agents and their effectiveness has been shown to be
relatively limited and is associated with potential unwanted effects. Therefore, the
discovery of new medications that can facilitate abstinence and reduce relapse to cigarette
use represents a pressing necessity. In the attempt to find molecules that could reduce
drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not
food, seeking behavior in rats. This discovery of a new therapeutic application for an
already marketed class of compounds may greatly facilitate the translation from preclinical
to clinical setting. In this project, we aim at investigating whether simvastatin is an
effective smoking cessation agent in humans.
The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial
with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin
or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo)
will be recruited through already established networks of general practitioners. The primary
outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last
month of the 3-month treatment period, defined as reported continuous abstinence from smoking
and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last
assessment will be done 6 months after the predefined quit date.
The results of this proof-of-concept study may open new perspectives in the treatment of
tobacco use and dependance.
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