Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03170258 |
Other study ID # |
Pro00081458 |
Secondary ID |
UL1TR00111724393 |
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 28, 2018 |
Est. completion date |
July 5, 2022 |
Study information
Verified date |
June 2023 |
Source |
Duke University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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 fMRI and/or EEG 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 are also free to provide photos they already have by
uploading them to a secure website or brining them in on a device (e.g., thumbdrive).
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 Brain Imaging and Analysis Center (BIAC) and/or the UNC Biomedical Research Imaging
Center (BRIC). 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. 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.