Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Self-activation in Individuals With and Without Nicotine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170258
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : April 25, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE May 26, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE February 28, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Change in reward-related brain activation [ Time Frame: Changes will be assessed across the task (~30 minutes) during the neurofeedback visit ]
The investigators will examine the change in brain activation in the target region (e.g., VTA) during the task. This includes prior to, during, and following real-time neurofeedback.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
Percent signal change in VTA BOLD activation [ Time Frame: Changes will be assessed across the task (~30 minutes) during the MRI visit ]
The investigators will examine the % signal change in VTA BOLD activation during the task, prior to, during, and following real-time fMRI neurofeedback.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Dopamine availability [ Time Frame: Collected once during the screening visit ]
    Dopamine availability as assessed by genetic saliva samples
  • Onset to smoking a cigarette [ Time Frame: To occur following the neurofeedback session, up to 30 minutes following the session ]
    We will measure the time (in minutes) to when participants smoke their first cigarette following the MRI session
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2017)
  • Dopamine availability [ Time Frame: Collected once during the screening visit ]
    Dopamine availability as assessed by genetic saliva samples
  • Onset to smoking a cigarette [ Time Frame: To occur following the MRI session, up to 30 minutes following the scan session ]
    We will measure the time (in minutes) to when participants smoke their first cigarette following the MRI session
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-activation in Individuals With and Without Nicotine Dependence
Official Title  ICMJE Self-activation of Reward-related Brain Regions in Individuals With and Without Nicotine Dependence
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Addiction Nicotine
Intervention  ICMJE Device: Neurofeedback (from fMRI and/or EEG)
During part of the task, a feedback display (e.g., thermometer stimulus) will be used to display the average brain activity for each participant. This signal will be acquired ~ every 1 second during the neurofeedback session and will dynamically update to reflect ongoing changes in brain activity. This continuously updated display is the primary feedback mechanism provided to the participant.
Study Arms  ICMJE
  • Experimental: Reward-related Brain Region Feedback
    Participants in this group will receive neurofeedback from a reward-related brain area (e.g., VTA, PFC) using EEG and/or fMRI during the experiment.
    Intervention: Device: Neurofeedback (from fMRI and/or EEG)
  • Sham Comparator: Noise Control
    Participants in this group will receive sham neurofeedback. Both groups will be debriefed at the end of the study.
    Intervention: Device: Neurofeedback (from fMRI and/or EEG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 20, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2017)
70
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kathryn Dickerson, PhD 919-668-6091 kathryn.dickerson@duke.edu
Contact: R. Alison Adcock, MD, PhD 919-681-7486 alison.adcock@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03170258
Other Study ID Numbers  ICMJE Pro00081458
UL1TR001117 ( U.S. NIH Grant/Contract )
24393 ( Other Grant/Funding Number: Brain & Behavior Research Foundation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: We plan to upload the fMRI statistical image maps on NeuroVault. We will do so after data collection is complete.
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Brain & Behavior Research Foundation
Investigators  ICMJE
Principal Investigator: Kathryn Dickerson, PhD Duke University
PRS Account Duke University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP