fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

NCT ID: NCT03595293

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-02-29

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".

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

fNIRs-based Neurofeedback

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham feedback

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

fNIRs-based Neurofeedback

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham feedback

Intervention Type: DEVICE

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

Interventions

fNIRs-based Neurofeedback

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

Intervention Type: DEVICE

Sham feedback

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sue Grigson

Professor and Chair, Department of Neural and Behavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patricia S Grigson, PhD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Other Identifiers

8203

Identifier Type: -

Identifier Source: org_study_id