Clinical trial NCT03170258: Self-activation in Individuals With and Without Nicotine Dependence
Official title: Self-activation of Reward-related Brain Regions in Individuals With and Without Nicotine Dependence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Addiction Nicotine
Keywords: real-time fMRI
reward
motivation
dopamine
EEG
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Brain & Behavior Research Foundation
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-05-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. 18-45 years of age
2. Right handed
3. In good general health
4. Male or Female
5. For ND individuals: Self-reported smoking ≥ 5 combustible cigarettes per day
6. For ND individuals: Afternoon expired CO concentration of ≥ 8 ppm
7. For ND individuals: 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. Current or past 6 month diagnosis of anxiety, bipolar disorder, depression, OCD, schizophrenia, psychosis, or personality disorder.
4. Current substance abuse or dependence or history within the last 6 months (other than nicotine for ND individuals)
5. For ND individuals: Positive drug test for anything other than marijuana
6. For ND individuals: Currently on nicotine replacement therapy
7. For ND individuals: Individuals who role their own cigarettes
8. For ND individuals: Daily cannabis use
9. For ND individuals: Consume more than 21 alcoholic drinks per week
10. For ND individuals: Use harder drugs (e.g., cocaine, methamphetamine) more than 10 times per year
11. For ND individuals: Currently taking medication that directly acts on the dopamine system (e.g., L-DOPA).
12. Inability to understand written and/or spoken English language
13. For MRI subjects: Claustrophobia or other contraindications to MRI scanning
14. For MRI subjects: If female, pregnancy as determined by urine pregnancy test on the day of MRI scanning
15. For MRI subjects: Presence of any metal in the body (e.g., implant, non-removable piercing, metal IUD)
16. For MRI subjects: Head injury resulting in loss of consciousness
17. For MRI subjects: Worked with metal (e.g., welding) or had an injury to the eye involving metal
18. For MRI subjects: Weigh more than 250 pounds

Primary outcomes:
measure: Percent Change in Reward-related Brain Activation as Measured by fMRI
timeFrame: Changes will be assessed across the task (~30 minutes) during the neurofeedback visit
measure: Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power
timeFrame: Baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback
Secondary outcomes:
measure: Dopamine Availability
timeFrame: Collected once during the screening visit
measure: Onset to Smoking a Cigarette
timeFrame: up to 30 minutes following the neurofeedback session
Other outcomes:
Locations:
city: Durham
country: United States
facility: Center for Cognitive Neuroscience
state: North Carolina
Study officials:
affiliation: Duke University
name: R. Alison Adcock, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: