WithdrawnNot Applicable

fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD

Stopped: Covid-19 related delays made initiation of the project untenable

0Started 2026-01-01

Plain-language 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".

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: First two weeks of protocol

Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions.

Timeframe: First two weeks of protocol

Higher levels of abstinence 90-days post-residential treatment completion as assessed by the 7-day timeline followback questionnaires.

Timeframe: First 90 days after treatment completion at Caron Treatment Center

Trial details

NCT IDNCT03595293

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Alcohol Use Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: First two weeks of protocol

Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions.

Timeframe: First two weeks of protocol

Higher levels of abstinence 90-days post-residential treatment completion as assessed by the 7-day timeline followback questionnaires.

Timeframe: First 90 days after treatment completion at Caron Treatment Center