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Self-activation in Individuals With and Without Nicotine Dependence

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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

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.

Condition or disease Intervention/treatment Phase
Addiction Nicotine Device: Neurofeedback (from fMRI and/or EEG) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Self-activation of Reward-related Brain Regions in Individuals With and Without Nicotine Dependence
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
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.
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.

Sham Comparator: Noise Control
Participants in this group will receive sham neurofeedback. Both groups will be debriefed at the end of the study.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Dopamine availability [ Time Frame: Collected once during the screening visit ]
    Dopamine availability as assessed by genetic saliva samples

  2. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170258


Contacts
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Contact: Kathryn Dickerson, PhD 919-668-6091 kathryn.dickerson@duke.edu
Contact: R. Alison Adcock, MD, PhD 919-681-7486 alison.adcock@duke.edu

Locations
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United States, North Carolina
Center for Cognitive Neuroscience Recruiting
Durham, North Carolina, United States, 27708
Contact: Kathryn Dickerson, PhD    919-668-6091    kathryn.dickerson@duke.edu   
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Kathryn Dickerson, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03170258    
Other Study ID Numbers: Pro00081458
UL1TR001117 ( U.S. NIH Grant/Contract )
24393 ( Other Grant/Funding Number: Brain & Behavior Research Foundation )
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Duke University:
real-time fMRI
reward
motivation
dopamine
EEG
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action