Addiction NicotineNCT03170258
Self-activation in Individuals With and Without Nicotine Dependence
A study testing Neurofeedback (from fMRI and/or EEG) in people with Addiction Nicotine, run by Duke University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Addiction Nicotine
- What is being tested?
- Neurofeedback (from fMRI and/or EEG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age
- Right handed
- In good general health
- Male or Female
- For ND individuals: Self-reported smoking ≥ 5 combustible cigarettes per day
- For ND individuals: Afternoon expired CO concentration of ≥ 8 ppm
- For ND individuals: Is willing and able to abstain from smoking for a few hours
Who cannot join
- History of chronic/significant medical condition
- Current or past 6 month use of prescription medications for psychiatric conditions (e.g., depression, anxiety)
- Current or past 6 month diagnosis of anxiety, bipolar disorder, depression, OCD, schizophrenia, psychosis, or personality disorder.
- Current substance abuse or dependence or history within the last 6 months (other than nicotine for ND individuals)
- For ND individuals: Positive drug test for anything other than marijuana
- For ND individuals: Currently on nicotine replacement therapy
Show all 18Show fewer
- For ND individuals: Individuals who role their own cigarettes
- For ND individuals: Daily cannabis use
- For ND individuals: Consume more than 21 alcoholic drinks per week
- For ND individuals: Use harder drugs (e.g., cocaine, methamphetamine) more than 10 times per year
- For ND individuals: Currently taking medication that directly acts on the dopamine system (e.g., L-DOPA).
- Inability to understand written and/or spoken English language
- For MRI subjects: Claustrophobia or other contraindications to MRI scanning
- For MRI subjects: If female, pregnancy as determined by urine pregnancy test on the day of MRI scanning
- For MRI subjects: Presence of any metal in the body (e.g., implant, non-removable piercing, metal IUD)
- For MRI subjects: Head injury resulting in loss of consciousness
- For MRI subjects: Worked with metal (e.g., welding) or had an injury to the eye involving metal
- For MRI subjects: Weigh more than 250 pounds
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Cognitive Neuroscience
Durham, North Carolina, 27708
About this study
Official title: 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.
Read the detailed description
The purpose of this study is to:
- 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).
- Evaluate whether fMRI and/or EEG neurofeedback improves the ability to increase reward-related brain activation in individuals with and without ND.
- Examine the relationship between activation of reward-related regions via neurofeedback and dopamine availability (as assessed genetically).
- 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.
- Conditions
- Addiction Nicotine
- Being tested
- Neurofeedback (from fMRI and/or EEG)
- Keywords
- real-time fMRI, reward, motivation, dopamine, EEG
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback (from fMRI and/or EEG)Device
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 group | Role | What they receive |
|---|---|---|
| Reward-related Brain Region Feedback | Experimental | 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. Receives: Device: Neurofeedback (from fMRI and/or EEG) |
| Noise Control | Sham comparator | Participants in this group will receive sham neurofeedback. Participants will be debriefed at the end of the study. Receives: Device: Neurofeedback (from fMRI and/or EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Reward-related Brain Activation as Measured by fMRI
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. Reported is the percent signal change from baseline (last 3 volumes of prior count condition).
Measured: Changes will be assessed across the task (~30 minutes) during the neurofeedback visit
Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power
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. Reported here is the change from baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback. The ratio of Beta to Theta power indicates the level of active brainwave activity (Beta) versus the level of resting brainwave activity (Theta).
Measured: Baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback
Secondary outcomes (2)
Dopamine Availability
Dopamine availability as assessed by genetic saliva samples
Measured: Collected once during the screening visit
Onset to Smoking a Cigarette
The time (in minutes) to when participants smoke their first cigarette following the MRI session
Measured: up to 30 minutes following the neurofeedback session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start28 Feb 2018
- Primary completion28 Jun 2022
- Study completion5 Jul 2022
Why it stopped: unanticipated difficulty with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Addiction NicotineStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Brain & Behavior Research Foundation, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- R. Alison Adcock, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170258
- Sponsor's protocol ID
- Pro00081458
- Other IDs
- UL1TR001117, 24393
- Status last verified
- Aug 2024
- First submitted
- 26 May 2017
- Last updated
- 5 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We plan to upload the fMRI statistical image maps on NeuroVault. We will do so after data collection is complete.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-activation of Reward-related Brain Regions in Individuals With and Without Nicotine Dependence
- ClinicalTrials.gov ID
- NCT03170258
- Acronym / sponsor ID
- Pro00081458
- Conditions
- Addiction Nicotine
- Keywords
- real-time fMRI, reward, motivation, dopamine, EEG
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unanticipated difficulty with enrollment
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Brain & Behavior Research Foundation, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 5 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Evaluate whether fMRI and/or EEG neurofeedback improves the ability to increase reward-related brain activation in individuals with and without ND.
- Examine the relationship between activation of reward-related regions via neurofeedback and dopamine availability (as assessed genetically).
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reward-related Brain Region Feedback | Experimental | Device: Neurofeedback (from fMRI and/or EEG)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. |
| Noise Control | Sham comparator | Device: Neurofeedback (from fMRI and/or EEG)Participants in this group will receive sham neurofeedback. Participants will be debriefed at the end of the study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-45 years of age
- Right handed
- In good general health
- Male or Female
- For ND individuals: Self-reported smoking ≥ 5 combustible cigarettes per day
Key exclusion criteria (18 listed)
- History of chronic/significant medical condition
- Current or past 6 month use of prescription medications for psychiatric conditions (e.g., depression, anxiety)
- Current or past 6 month diagnosis of anxiety, bipolar disorder, depression, OCD, schizophrenia, psychosis, or personality disorder.
- Current substance abuse or dependence or history within the last 6 months (other than nicotine for ND individuals)
- For ND individuals: Positive drug test for anything other than marijuana
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Noise Control, Reward-related Brain Region Feedback |
Primary outcome
Percent Change in Reward-related Brain Activation as Measured by fMRI
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. Reported is the percent signal change from baseline (last 3 volumes of prior count condition).
Change in Reward-related Brain Activation as Measured by EEG Ratio of Beta to Theta Power
Time frame: Baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback
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. Reported here is the change from baseline (prior to real-time neurofeedback) and ~30 minutes following real-time neurofeedback. The ratio of Beta to Theta power indicates the level of active brainwave activity (Beta) versus the level of resting brainwave activity (Theta).
2 secondary outcomes
Dopamine Availability
Time frame: Collected once during the screening visit
Onset to Smoking a Cigarette
Time frame: up to 30 minutes following the neurofeedback session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We plan to upload the fMRI statistical image maps on NeuroVault. We will do so after data collection is complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. Alison Adcock, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback (from fMRI and/or EEG) in people with Addiction Nicotine, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Reward-related Brain Activation as Measured by fMRI (time frame: Changes will be assessed across the task (~30 minutes) during the neurofeedback visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.