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fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

Primary Purpose

Alcohol Use Disorder, Alcoholism, Prescription Drug Dependence

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fNIRs-based Neurofeedback
Sham feedback
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Prescription Opioid Use Disorder, Alcohol Use Disorder, Functional Near-infrared Spectroscopy, Treatment Outcome, Resisting Craving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • sex: male or female
  • Age: greater than or equal to 18 years
  • Caron Treatment Center residential patients with alcohol use disorder, moderate to severe (equivalent to Alcohol Dependence in DSM-IV-TR), or prescription opioid use disorder (pOUD)
  • Fluent in written and spoken English
  • Patients who are right-handed
  • Valid email address and reliable internet access after leaving the Caron Treatment Center

Exclusion Criteria:

  • Patients who are concurrently receiving a psychoactive drug for the treatment of an Axis I disorder.
  • Patients with current major depressive disorder or schizophrenia, bipolar disorder, post-traumatic stress disorder, or a history of traumatic brain injury.
  • Decisional impairment
  • Adults unable to consent
  • Women who are pregnant
  • Prisoners
  • Patients who are left-handed
  • No reliable email addresses

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Sham Comparator

    Experimental

    Sham Comparator

    Arm Label

    Experimental Group for AUD Patients

    Sham Feedback Group for AUD Patients

    Experimental Group for pOUD Patients

    Sham Feedback Group for pOUD Patients

    Arm Description

    Patients will undergo six NFB sessions from the rDLPFC using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with an alcohol image, blocking them from progressing through the maze. When patients encounter the alcohol image and they increase activity in their rDLPFC, the image in the maze will decrease in size and vice versa. The size of the alcohol image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the rDLPFC will be sampled every 500 milliseconds using COBI studio software.

    Patients will undergo six sham feedback sessions from the skin over the zygomatic arch using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with an alcohol image, blocking them from progressing through the maze. When participants encounter the alcohol image and they increase blood supply over the zygomatic area, the image will decrease in size and vice versa. The size of the alcohol image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the zygomatic area will be sampled every 500 milliseconds using COBI studio software.

    Patients will undergo six NFB sessions from the rDLPFC using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with a pill image, blocking them from progressing through the maze. When patients encounter the pill image and they increase activity in their rDLPFC, the image in the maze will decrease in size and vice versa. The size of the pill image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the rDLPFC will be sampled every 500 milliseconds using COBI studio software.

    Patients will undergo six sham feedback sessions from the skin over the zygomatic arch using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with a pill image, blocking them from progressing through the maze. When participants encounter the pill image and they increase blood supply over the zygomatic area, the image will decrease in size and vice versa. The size of the pill image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the zygomatic area will be sampled every 500 milliseconds using COBI studio software.

    Outcomes

    Primary Outcome Measures

    Improved capacity to increase neural activity in response to alcohol/pill cues in the rDLPFC measured by the change in the blood-oxygen level dependent (BOLD) signal
    Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions.
    Increase in neural activation in the rDLPFC when viewing alcohol cues from the first neurofeedback session to the sixth (last) session.
    Higher levels of abstinence 90-days post-residential treatment completion as assessed by the 7-day timeline followback questionnaires.
    7-day timeline followback questionnaire will be sent out every week for 12 weeks to assess abstinence

    Secondary Outcome Measures

    Change in self-reported self-efficacy from pre-to-post neurofeedback sessions assessed via the brief situational confidence questionnaire.
    Before and after each neurofeedback session, participants will complete a brief situational confidence questionnaire
    Change in self-reported craving from pre-to-post neurofeedback sessions assessed via a 100-point craving visual analog scale.
    Before and after each neurofeedback session, participants will complete a 100-point craving visual analog scale

    Full Information

    First Posted
    June 29, 2018
    Last Updated
    February 24, 2023
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03595293
    Brief Title
    fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD
    Official Title
    Functional Near Infrared Spectroscopy-based Neurofeedback to Reduce Relapse in Prescription Opioid/Alcohol Use Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    February 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will examine the impact of functional near-infrared spectroscopy-based neurofeedback to a region within the brain's prefrontal cortex involved with self-regulation of resisting craving in alcohol use and prescription opioid use disorder patients. Participants will be asked to complete two cue reactivity tasks, six sessions of neurofeedback training as well as craving visual analog scales and self-efficacy questionnaires throughout a two-week period of their time in residential treatment at the Caron Treatment Center. They will be followed for 90 days after treatment completion at Caron to assess the impact neurofeedback had on their ability to remain sober once patients are living back in the "real world".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Use Disorder, Alcoholism, Prescription Drug Dependence, Opioid-use Disorder, Neurofeedback
    Keywords
    Prescription Opioid Use Disorder, Alcohol Use Disorder, Functional Near-infrared Spectroscopy, Treatment Outcome, Resisting Craving

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group for AUD Patients
    Arm Type
    Experimental
    Arm Description
    Patients will undergo six NFB sessions from the rDLPFC using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with an alcohol image, blocking them from progressing through the maze. When patients encounter the alcohol image and they increase activity in their rDLPFC, the image in the maze will decrease in size and vice versa. The size of the alcohol image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the rDLPFC will be sampled every 500 milliseconds using COBI studio software.
    Arm Title
    Sham Feedback Group for AUD Patients
    Arm Type
    Sham Comparator
    Arm Description
    Patients will undergo six sham feedback sessions from the skin over the zygomatic arch using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with an alcohol image, blocking them from progressing through the maze. When participants encounter the alcohol image and they increase blood supply over the zygomatic area, the image will decrease in size and vice versa. The size of the alcohol image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the zygomatic area will be sampled every 500 milliseconds using COBI studio software.
    Arm Title
    Experimental Group for pOUD Patients
    Arm Type
    Experimental
    Arm Description
    Patients will undergo six NFB sessions from the rDLPFC using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with a pill image, blocking them from progressing through the maze. When patients encounter the pill image and they increase activity in their rDLPFC, the image in the maze will decrease in size and vice versa. The size of the pill image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the rDLPFC will be sampled every 500 milliseconds using COBI studio software.
    Arm Title
    Sham Feedback Group for pOUD Patients
    Arm Type
    Sham Comparator
    Arm Description
    Patients will undergo six sham feedback sessions from the skin over the zygomatic arch using a closed-loop fNIRs-based system. During each session, participants will walk through a maze on a computer screen three times. Each maze consists of alternating 30-second rest and 30-second active blocks. During each active block, the participant will come into visual contact with a pill image, blocking them from progressing through the maze. When participants encounter the pill image and they increase blood supply over the zygomatic area, the image will decrease in size and vice versa. The size of the pill image can fluctuate throughout each thirty second active block as the raw fNIRs signal from the zygomatic area will be sampled every 500 milliseconds using COBI studio software.
    Intervention Type
    Device
    Intervention Name(s)
    fNIRs-based Neurofeedback
    Intervention Description
    Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.
    Intervention Type
    Device
    Intervention Name(s)
    Sham feedback
    Intervention Description
    Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.
    Primary Outcome Measure Information:
    Title
    Improved capacity to increase neural activity in response to alcohol/pill cues in the rDLPFC measured by the change in the blood-oxygen level dependent (BOLD) signal
    Time Frame
    First two weeks of protocol
    Title
    Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions.
    Description
    Increase in neural activation in the rDLPFC when viewing alcohol cues from the first neurofeedback session to the sixth (last) session.
    Time Frame
    First two weeks of protocol
    Title
    Higher levels of abstinence 90-days post-residential treatment completion as assessed by the 7-day timeline followback questionnaires.
    Description
    7-day timeline followback questionnaire will be sent out every week for 12 weeks to assess abstinence
    Time Frame
    First 90 days after treatment completion at Caron Treatment Center
    Secondary Outcome Measure Information:
    Title
    Change in self-reported self-efficacy from pre-to-post neurofeedback sessions assessed via the brief situational confidence questionnaire.
    Description
    Before and after each neurofeedback session, participants will complete a brief situational confidence questionnaire
    Time Frame
    First two weeks of protocol
    Title
    Change in self-reported craving from pre-to-post neurofeedback sessions assessed via a 100-point craving visual analog scale.
    Description
    Before and after each neurofeedback session, participants will complete a 100-point craving visual analog scale
    Time Frame
    First two weeks of protocol

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: sex: male or female Age: greater than or equal to 18 years Caron Treatment Center residential patients with alcohol use disorder, moderate to severe (equivalent to Alcohol Dependence in DSM-IV-TR), or prescription opioid use disorder (pOUD) Fluent in written and spoken English Patients who are right-handed Valid email address and reliable internet access after leaving the Caron Treatment Center Exclusion Criteria: Patients who are concurrently receiving a psychoactive drug for the treatment of an Axis I disorder. Patients with current major depressive disorder or schizophrenia, bipolar disorder, post-traumatic stress disorder, or a history of traumatic brain injury. Decisional impairment Adults unable to consent Women who are pregnant Prisoners Patients who are left-handed No reliable email addresses
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Christopher Freet, PhD
    Phone
    7175310003
    Ext
    286287
    Email
    cfreet@pennstatehealth.psu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Scott Bunce, PhD
    Phone
    7175314127
    Email
    sbunce@pennstatehealth.psu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia S Grigson, PhD
    Organizational Affiliation
    Milton S. Hershey Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not plan to share individual participant data.

    Learn more about this trial

    fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

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