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Real-Time fMRI to Enhance Interventions That Change Delay Discounting (RP2B)

Primary Purpose

Alcohol Use Disorder (AUD)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real Time Neurofeedback
"Idealized"/Sham Neurofeedback
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder (AUD) focused on measuring Alcohol Use Disorder (AUD), rt-fMRI, behavioral economics

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • demonstrate high-risk or harmful drinking (AUDIT>15)
  • be 21 years of age or older
  • have a desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for AUD during the study period

Exclusion Criteria:

  • meeting moderate to severe DSM-5 criteria for substance-use disorders other than alcohol or nicotine
  • having a current diagnosis of any psychotic disorder
  • having a history of seizure disorders or traumatic brain injury
  • having any contraindication for participation in the MRI sessions
  • reporting current pregnancy or lactation

Sites / Locations

  • Fralin Biomedical Research Institute at VTCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real Time Neurofeedback

"Idealized"/Sham Neurofeedback

Arm Description

Real time neurofeedback will be based on a classifier of increasing or decreasing delay discounting fMRI patterns. Participants will try to modulate their discounting rate based on neurofeedback via a visual dial, during an fMRI scan. Participants will be told they will be controlling the visual dial.

Rather than using the output of a classifier, the visual dial will display perfect "modulation" of increasing and decreasing delay discounting and participants will told that they will not be controlling the visual dial.

Outcomes

Primary Outcome Measures

Delay Discounting
Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using the adjusting amount delay discounting and minute delay discounting tasks both inside and outside the fMRI. Pre-post differences will be assessed between real and idealized neurofeedback groups.
Delay Discounting
Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using the adjusting amount delay discounting and minute delay discounting tasks both inside and outside the fMRI. Pre-post differences will be assessed between real and idealized neurofeedback groups.
Alcohol Demand
Alcohol valuation will be assessed using BAAD interspersed with the neurofeedback periods (inside the scanner). Differences in alcohol demand will be compared between neurofeedback groups.
Alcohol Demand
Alcohol valuation will be assessed via the alcohol purchase task (outside the scanner). Differences in alcohol demand will be compared between neurofeedback groups.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2021
Last Updated
February 14, 2023
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Fralin Biomedical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04828577
Brief Title
Real-Time fMRI to Enhance Interventions That Change Delay Discounting
Acronym
RP2B
Official Title
Real-Time fMRI to Enhance Interventions That Change Delay Discounting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Fralin Biomedical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will use real-time fMRI neurofeedback to enhance participants' ability to control their temporal window, and hence their ability to modulate delay discounting and alcohol valuation.
Detailed Description
Based on 8 years of experience recruiting alcohol users into studies of comparable length and complexity, the investigators anticipate that 92% of consented participants will be eligible (i.e., randomized) and 97% of those individuals will complete Aim 2b. Thus, to achieve a final sample size of 100, the investigators anticipate consenting 111 participants. This study will include 50 real time fMRI (experimental group) participants and 50 "idealized" neurofeedback (control) participants. Participants will be randomly assigned to experimental or control groups, stratified by AUDIT scores, SES, age, and sex. All study procedures will take place during a single study visit. Before the imaging session, a research assistant will aid the participant to select salient images related to individualized future goals as well as alcohol images which elicit self-reported craving. All participants will complete two fMRI runs within a single session. In run 1 of the scan (offline classifier training), participants will perform an image viewing task displaying alternating blocks of these goal- and alcohol-related images. Between the image viewing blocks we will assess reinforcer pathology with brief in-scanner measures of delay discounting and alcohol valuation (BAAD). In total, there will be six blocks each of the goal-oriented images, alcohol-related images, delay discounting, and BAAD (24 blocks total). Since this is a proof-of-concept experiment, the interspersed delay discounting and BAAD blocks will enable monitoring and validating changes in the participant's temporal window and alcohol valuation after the image viewing blocks. Only the fMRI measures of goal- and alcohol-related image viewing will be used to build a support vector classifier (SVC) of decreased vs. increased delay discounting. If participants are allocated to the real time fMRI group, in run 2 the SVC model from run 1 will be used to provide participants with real-time neurofeedback while they attempt to modulate their temporal window. The participants will see a dial with a needle on the screen along with instructions to think of either future goals or alcohol cues. The dial will be directly controlled by ongoing output from the SVC, updating the needle position as participants imagine immediate (alcohol-related) or delayed (goal-related) cues. Control participants ("idealized" neurofeedback group) will undergo the same procedures, but in run 2 neurofeedback, will be presented with an "idealized" dial (perfect needle movements in both alcohol and goal directions) and will be specifically instructed that they are not controlling the interface. The investigators have used this type of sham needle movement as a control condition in previous experiments. Based on this, it is expected that experimental group will have increased whole brain signal to noise for alcohol vs. goal fMRI analyses and increased recruitment of frontal-parietal networks from enhanced visual attention to the task.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
Alcohol Use Disorder (AUD), rt-fMRI, behavioral economics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Time Neurofeedback
Arm Type
Experimental
Arm Description
Real time neurofeedback will be based on a classifier of increasing or decreasing delay discounting fMRI patterns. Participants will try to modulate their discounting rate based on neurofeedback via a visual dial, during an fMRI scan. Participants will be told they will be controlling the visual dial.
Arm Title
"Idealized"/Sham Neurofeedback
Arm Type
Sham Comparator
Arm Description
Rather than using the output of a classifier, the visual dial will display perfect "modulation" of increasing and decreasing delay discounting and participants will told that they will not be controlling the visual dial.
Intervention Type
Behavioral
Intervention Name(s)
Real Time Neurofeedback
Intervention Description
Participants receive feedback from own brain activity.
Intervention Type
Behavioral
Intervention Name(s)
"Idealized"/Sham Neurofeedback
Intervention Description
Participants receive idealized feedback not related to their own brain activity.
Primary Outcome Measure Information:
Title
Delay Discounting
Description
Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using the adjusting amount delay discounting and minute delay discounting tasks both inside and outside the fMRI. Pre-post differences will be assessed between real and idealized neurofeedback groups.
Time Frame
During the real time fMRI scan, approximately 1 hour
Title
Delay Discounting
Description
Delay discounting tasks provide a measure of the temporal window and examine the devaluation of awards as a function of the delay to the receipt. These computerized assessments provide participants with hypothetical choices between smaller amounts of a reward available immediately and a larger amount of a reward after a range of delays (1 day-25 years). Discounting rates will be measured using the adjusting amount delay discounting and minute delay discounting tasks both inside and outside the fMRI. Pre-post differences will be assessed between real and idealized neurofeedback groups.
Time Frame
Immediately following the real time fMRI scan
Title
Alcohol Demand
Description
Alcohol valuation will be assessed using BAAD interspersed with the neurofeedback periods (inside the scanner). Differences in alcohol demand will be compared between neurofeedback groups.
Time Frame
During the real time fMRI scan, approximately 1 hour
Title
Alcohol Demand
Description
Alcohol valuation will be assessed via the alcohol purchase task (outside the scanner). Differences in alcohol demand will be compared between neurofeedback groups.
Time Frame
Immediately following the real time fMRI scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: demonstrate high-risk or harmful drinking (AUDIT>15) be 21 years of age or older have a desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for AUD during the study period Exclusion Criteria: meeting moderate to severe DSM-5 criteria for substance-use disorders other than alcohol or nicotine having a current diagnosis of any psychotic disorder having a history of seizure disorders or traumatic brain injury having any contraindication for participation in the MRI sessions reporting current pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy E Myslowski
Phone
5405262015
Email
jem5782@vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M LaConte, PhD
Organizational Affiliation
Fralin Biomedical Research Institute (FBRI) at VTC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren K Bickel, PhD
Organizational Affiliation
Fralin Biomedical Research Institute (FBRI) at VTC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fralin Biomedical Research Institute at VTC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Glenn
Phone
540-526-2014
Email
sglenn@vtc.vt.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators will adhere to all NIH requirements regarding data sharing. Participant data collected in this project will be de-identified and made available on a shared secured data repository. We will also share the analysis results. As part of this process, all investigators will be required to agree to the following conditions: 1) will adhere to the reporting responsibilities; 2) will not redistribute the data beyond the requesting individual and named collaborators; 3) will give appropriate acknowledgement; 4) will not use the data for commercial purposes; and 5) will obtain appropriate ethical approvals. Results from research conducted will be shared and disseminated, including: regular project meetings, annual meetings, symposia, workshops, and/or conferences for related groups. Manuscripts will be written and submitted for publication in peer-reviewed journals/conferences, following the NIH Public Access Policy guidelines. All necessary ethical approvals will be obtained.
IPD Sharing Time Frame
Data will be made available upon request after dissemination of results.
IPD Sharing Access Criteria
Data requests will be reviewed by the principal investigator and data will be shared with the expectation of acknowledgment of funding source and primary study team.

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Real-Time fMRI to Enhance Interventions That Change Delay Discounting

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