fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

Milton S. Hershey Medical Center

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Alcohol Use Disorder Alcoholism Prescription Drug Dependence Opioid-use Disorder Neurofeedback

Interventions

fNIRs-based NeurofeedbackDEVICE

Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.

Sham feedbackDEVICE

Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

Time frame: 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

Time frame: First 90 days after treatment completion at Caron Treatment Center

Secondary Outcomes

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

Time frame: 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

Time frame: First two weeks of protocol

Data from ClinicalTrials.gov

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