fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03595293
• Other study ID #: 8203
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2026
• Est. completion date: February 2028

Study information

• Verified date: January 2024
• Source: Milton S. Hershey Medical Center
• Contact: Christopher Freet, PhD
• Phone: 7175310003
• Email: cfreet[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2028
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Neurofeedback
• Opioid-Related Disorders
• Opioid-use Disorder
• Prescription Drug Dependence
• Substance-Related Disorders

Intervention

Device:
• fNIRs-based Neurofeedback
Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.
• Sham feedback
Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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