fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

Functional Near Infrared Spectroscopy-based Neurofeedback to Reduce Relapse in Prescription Opioid/Alcohol Use Disorders

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".

Study Overview

• Status: Withdrawn
• Conditions: Alcoholism; Alcohol Use Disorder; Opioid-use Disorder; Neurofeedback; Prescription Drug Dependence
• Intervention / Treatment: Device: fNIRs-based Neurofeedback; Device: Sham feedback

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group for AUD Patients; 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.	Device: fNIRs-based Neurofeedback; Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.
Sham Comparator: Sham Feedback Group for AUD Patients; 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.	Device: Sham feedback; Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.
Experimental: Experimental Group for pOUD Patients; 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.	Device: fNIRs-based Neurofeedback; Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.
Sham Comparator: Sham Feedback Group for pOUD Patients; 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.	Device: Sham feedback; Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		First two weeks of protocol
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.	First two weeks of protocol
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	First 90 days after treatment completion at Caron Treatment Center

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	First two weeks of protocol
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	First two weeks of protocol

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Patricia S Grigson, PhD, Milton S. Hershey Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Alcohol Use Disorder; Treatment Outcome; Prescription Opioid Use Disorder; Functional Near-infrared Spectroscopy; Resisting Craving
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Opioid-Related Disorders; Alcoholism; Alcohol Drinking; Substance-Related Disorders
• Other Study ID Numbers: 8203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data.

Drug and device information, study documents

• 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