Effect of Varenicline on Tobacco Addiction and on Abstinence-induced Cognitive Impairment
Status:
Withdrawn
Trial end date:
2014-11-26
Target enrollment:
Participant gender:
Summary
Background:
- Varenicline (Chantix ) is a drug that is approved by the Food and Drug Administration (FDA)
to help people stop smoking. Varenicline is very effective in helping some people quit
smoking, but is less effective for others. Researchers are interested in conducting more
in-depth studies into how varenicline works, including its effect on smokers' responses to
items that may trigger cigarette cravings, in order to develop better smoking cessation
medications.
Objectives:
- To examine the effectiveness of varenicline as an effective medication for tobacco
addiction by studying its effect on nicotine reinforcement, nicotine-seeking behavior,
cue-elicited craving, and performance impairment and craving after overnight tobacco
deprivation.
Eligibility:
- Individuals between 18 and 50 years of age who have been smoking at least 10 cigarettes per
day for at least 2 years.
Design:
- This study will require 12 study visits. Some visits will be brief and other visits that
involve test sessions will last up to 8 hours. If no sessions are repeated, the study
will take 26 days. Participants will not be required to attempt to quit smoking during
this study.
- Participants will be screened with a full physical examination and medical history,
blood and urine tests, and other tests as required by the study researchers.
- Participants will take two sets of pills during the study: the first set during the
first 12 days of the study, followed by a 2-day break, then the second set during the
last 12 days. Some of the pills will contain varenicline, and others will be placebos.
- On Day 1 of the study, participants will come to the National Institute on Drug Abuse to
receive the first set of pills. Participants will take the first pill before leaving.
- On Day 8, participants will have a training session that will measure the amount of
carbon monoxide in the breath. Participants will also complete several questionnaires
about smoking habits and current mood, and will have a chance to practice the procedures
they will do in the study.
- On Days 9 and 10, participants will have behavioral test sessions that will last 7 to 8
hours. Day 9 will involve tests of cue response to items that may trigger cigarette
cravings, and tests of general nicotine cravings over several hours. Day 10 will involve
tests of general nicotine cravings over several hours, and then tests of
nicotine-seeking behavior. Participants will be provided with lunch during these all-day
sessions.
- On Day 11, participants will have memory and attention tests, and will provide a blood
sample. Participants will not be allowed to smoke for 12 hours before the start of the
next test on Day 12.
- On Day 12, participants will provide a breath sample, and will have two sets of memory
and attention tests before they will be permitted to start smoking again. There will be
no tests on Days 13 and 14.
- Starting on Day 15, participants will repeat the schedule of tests from Days 1 through
12 with the second set of pills.