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Pharmacogenetics, Emotional Reactivity and Smoking Cessation: Genetic Differences in Limbic Activation Associated With Nicotine Withdrawal

Phase 3
18 Years
Not Enrolling

Thank you

Trial Information

Pharmacogenetics, Emotional Reactivity and Smoking Cessation: Genetic Differences in Limbic Activation Associated With Nicotine Withdrawal

Before you begin participation in this study, you will be asked to provide the names and
addresses of 3 contacts (family member/friends) who will know your current contact
information. This is so study researchers can stay in contact with you throughout the study.
This is in case study researchers may need to reach you in order to reschedule your
appointment time. You will also be asked to sign a letter giving your contacts permission to
provide your contact information to the study staff.

If the staff is not able to reach you, they may try to locate you through telephone
directory assistance or the internet. If the study staff is still unable to locate you,
they may use a locator service, such as Transunion or the National Change of Address (NCOA)
database, which is maintained by the United States Postal Service.

If you agree to take part in this study, you will be asked to come to the Behavioral Science
Research Clinic at M. D. Anderson for up to 2 laboratory sessions. One session will be while
you are smoking, and one session will be while you are abstinent from smoking (not smoking).

At each of these sessions, you will have functional magnetic resonance imaging (fMRI) of
your brain while you are looking at slides. fMRI involves a scanner that uses a large
magnet, instead of x-rays, to take pictures of the inside of your body. The slides will
include pictures of people, nature scenes, artwork, victims of car crashes, medical
procedures (such as open surgery or autopsy), and nude people. You will be shown examples of
these slides before having the fMRI, and you will be given the opportunity to withdraw from
this study at that time. If you choose to continue on this study, you will have an fMRI
taken of your brain. This will involve being passed into a narrow tube-shaped scanner that
is open at both ends. During the fMRI, your brain electrical activity will be monitored.
The total time for each lab session will last about 1.5 hours.

You should not drink more than 2 cups of coffee or other caffeine drinks at least 2 1/2
hours before each session. This is because caffeine may affect brain functioning. Before
one or both of your sessions, you may be asked to not smoke from bedtime on the day before
the session until after the session on the next day. Before one or both of your sessions,
you may be asked to smoke as you would regularly. Additionally, you may be asked to smoke
during one or both of your laboratory sessions.

At each lab session, you will be asked to blow air through a carbon monoxide (CO) measuring
device. CO is a gas that is found (in higher levels) in the bodies of cigarette smokers. You
will also be asked questions about your smoking habits; your health and medical condition;
and about any medications you are taking. You will also be asked to complete some
questionnaires that will ask about your mood and feelings. You may be asked to complete
these questionnaires before, during, or after the fMRI.

At the end of this study, you will be able to ask questions about the results of this study
and about procedures you have experienced during this study.

Your participation in this part of the study will last about 2 weeks. It will end after your
last lab session. You will still be considered a participant in the main study (Protocol
2003-1024) and may have additional visits, questionnaires, and other activities to complete.

This is an investigational study. Up to 72 participants will take part in this study. All
will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Subject must be a participant in 'Pharmacogenetics, Emotional Reactivity & Smoking'
(protocol 2003-1024).

2. Both parents must be of European descent. The sample will be limited to individuals
of European descent because the majority of the published work on the genes of
interest has been limited to this racial group. This has been done mostly to prevent
population stratification in genetic studies, since allele frequency differences
often exist among groups with differing continents of origin.

3. Right handed. The sample is limited to right handed individuals since we will analyze
our neuroimaging data for lateralization effects and inclusion of participants of
mixed handedness could confound the results.

4. Age: 18 years or older

Exclusion Criteria:

1. Contraindications for MR imaging procedures (e.g., subjects with certain types of
implanted medical devices, such as pacemakers, neurostimulators, etc., or subjects who are

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Stimulus type (positive, negative, neutral, cigarette) by group (Bupropion/ Varenicline/Placebo)

Outcome Time Frame:

Pre-quit to 1-2 days post-quit

Safety Issue:


Principal Investigator

Paul Cinciripini, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

Related Keywords:

  • Smoking
  • Smoking
  • Smoking Cessation
  • Nicotine Withdrawal
  • Nicotine Dependence
  • Neuroregulatory Effects
  • Magnetic Resonance Imaging
  • MRI
  • Substance Withdrawal Syndrome
  • Smoking



UT MD Anderson Cancer Center Houston, Texas  77030