The Effect of Acetylcholinesterase Inhibitors on Smoking Behavior
Nicotine dependence is a major public health problem and currently available treatments are
ineffective for the majority of smokers. Thus, there is a need to develop and test novel
medications to assist smokers to quit smoking. Recent evidence from two genetic studies by
our group implicates the endogenous cholinergic system in smoking cessation and nicotine
dependence, Pre-clinical investigations have also demonstrated an important role for the
endogenous cholinergic system in nicotine addiction. The proposed proof of concept pilot
study is a randomized Phase 2a trial designed to study the effects of Donepezil
hydrochloride (HCL) (Aricept), compared to placebo, on smoking behavior in 24 smokers. Key
outcomes include, adherence, side effects, smoking rate, and smoking topography.
Masking: Double-Blind, Primary Purpose: Supportive Care
At each visit, the participant will smoke a cigarette using a portable, hand held smoking topography device. The topography machine which will measure number of puffs, puff volume, puff velocity, interpuff interval, and peak velocity for each puff. The primary outcome measures will be the number of puffs and total puff volume.
Andrew Strasser, MBBS, PhD
Abramson Cancer Center of the University of Pennsylvania
United States: Food and Drug Administration
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