Galantamine Effects on Nicotine Responses in Smokers
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
This will be a 2-4 week double-blind, placebo-controlled study. Twenty four male and female
smokers will first have two 4-day treatment periods, in which they will be randomized to
galantamine (8 mg/day) or placebo. These treatment periods will be separated by a 3 to 14 day
washout period. During the first 3-days of each treatment period, smokers will have daily
clinic visits, where they will receive study medications and any adverse effects from study
medications will be monitored. Starting at 10 p.m. on Day 1 of each treatment period,
subjects will refrain from smoking for approximately 2.5 days, until the experimental session
on Day 4. Compliance with non-smoking will be verified by CO levels < 10 ppm. During the
experimental sessions, subjects will receive saline or 1.0 mg/70 kg of nicotine intravenously
in a random, double-blind manner. The sequence of nicotine treatments will be counterbalanced
among subjects such that equal number of subjects will receive saline first or nicotine
first. Following each saline and nicotine treatments, physiological, subjective and cognitive
measurements will be obtained