Self-activation in Individuals With and Without Nicotine Dependence



Status:Recruiting
Conditions:Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 45
Updated:4/17/2018
Start Date:February 28, 2018
End Date:April 2019
Contact:Kathryn Dickerson, PhD
Email:kathryn.dickerson@duke.edu
Phone:919-668-6091

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Self-activation of Reward-related Brain Regions in Individuals With and Without Nicotine Dependence

The purpose of this study is to see if a non-medication intervention can increase motivation
and reward processing to non-drug reward cues (for example, a picture of one's favorite food)
in individuals with and without nicotine dependence by observing brain activity using
electroencephalography (EEG) and/or functional magnetic resonance imaging (fMRI). The
investigators hypothesize that learning to increase brain activity to non-drug cues may
improve reward responses and motivation to non-drug cues, and for individuals who smoke, may
eventually result in improved smoking cessation outcomes.

The purpose of this study is to:

1. Assess the ability of adults with and without nicotine dependence (ND) to activate
reward-related brain regions (e.g., ventral tegmental area (VTA), striatum, prefrontal
cortex).

2. Evaluate whether Real-Time functional Magnetic Resonance Imaging (rt-fMRI) neurofeedback
improves the ability to increase reward-related brain activation in individuals with and
without ND.

3. Examine the relationship between activation of reward-related regions via neurofeedback
and dopamine availability (as assessed genetically).

4. Examine the effects of neurofeedback on clinically relevant outcomes, including reward
responsivity and smoking related behaviors.

Procedure:

Prior to coming to a screening visit, all potential participants will undergo a phone
pre-screening using an IRB approved phone script to pre-identify potentially eligible
participants and to potentially decrease screen fail rate. These interested potential
participants call or email the site in response to advertisements. The pre-screening will
take place via phone. Participants who pass the pre-screening will complete some or all of
the following visits: Screening, Camera Return Visit, Real-Time Neurofeedback Visit,
Follow-up Phone Call/Debriefing.

Screening Visit:

Participants with nicotine dependence who pass the pre-screen will come to the lab at Duke to
complete additional screening. All participants will undergo informed consent and those with
ND will complete a urine drug screen. Participants who pass the urine drug screen (results
are provided immediately) will complete questionnaires assessing mood, reward processing, and
smoking behaviors.

Some participants may also be given a camera to use to capture pictures of personalized
rewarding objects (e.g., picture of their pet, favorite book, favorite food). Participants
may be loaned the camera for a period of 1-2 weeks to capture pictures of rewarding objects.
We will instruct participants that the camera is to be used exclusively for capturing
pictures for the study and not for personal use. Some participants may not be asked to take
their own pictures for the study protocol and may simply be shown neutral or positive
pictures/images/objects provided by the experimenters (e.g., shapes, pictures, etc.). Note,
no aversive images will be shown to participants.

Camera Return Visit:

Participants who were loaned a camera will be asked to come to the lab at Duke to return the
camera. The experimenters will ensure that enough pictures have been acquired to use during
the experiment. Participants will be given guidelines about what types of pictures are
required for the study.

Participants may also be asked to view and rate the pictures they provide along with neutral
and positive images we provide (e.g., puppy, flower) on dimensions such as valence and
arousal.

Real-Time Neurofeedback Visit:

Eligible participants will be scheduled for an fMRI and/or EEG session to assess and measure
the ability to self-activate reward-related regions. The fMRI session will be conducted at
the Duke-UNC Brain Imaging and Analysis Center (BIAC). Female participants will have a urine
pregnancy test prior to fMRI scanning; the test will be verified to be negative in order to
proceed with the scanning session. The EEG sessions will take place in private testing space
in the Levine Science Research Center or the BIAC.

Participants may complete some or all of the following tasks: Reward Activation Task, Passive
Viewing Task, and Reward Learning Task. All of these tasks aim to assess how adults can learn
to interact with neurofeedback provided from an fMRI or EEG system. The tasks vary slightly
from each other in terms of stimuli used (personalized pictures, images provided by the
experimenters, feedback display, etc.). It may be possible that we will not be able to get a
good EEG signal for some participants, based on equipment error or head size. If this occurs,
participants will be debriefed and paid for their time. We will be sure to emphasize there
was no error on the participant's part, and that sometime the signal is difficult to acquire
for a variety of reasons.

Inclusion Criteria:

1. 18-45 years of age

2. Right handed

3. In good general health

4. Male or Female

5. Self-reported smoking ≥ 5 cigarettes per day and a FTND score of ≥ 3

6. Afternoon expired CO concentration of ≥ 10 ppm

7. Is willing and able to abstain from smoking for a few hours

Exclusion Criteria:

1. History of chronic/significant medical condition

2. Current or past 6 month use of prescription medications for psychiatric conditions
(e.g., depression, anxiety)

3. Meets criteria for any Axis I or II Disorder

4. Current substance abuse or dependence or history within the last 12 months, other than
nicotine

5. Inability to understand written and/or spoken English language

6. Claustrophobia or other contraindications to MRI scanning

7. If female, pregnancy as determined by urine pregnancy test on the day of MRI scanning

8. Presence of any metal in the body (e.g., implant, non-removable piercing, metal IUD)

9. Head injury resulting in loss of consciousness

10. Worked with metal (e.g., welding) or had an injury to the eye involving metal

11. Weigh more than 250 pounds
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Durham, North Carolina 27708
Phone: 919-668-6091
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