Alcohol Use DisorderNCT03595293
fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD
A study testing fNIRs-based Neurofeedback in people with Alcohol Use Disorder and Alcoholism, run by Milton S. Hershey Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder, Alcoholism, Prescription Drug Dependence
- What is being tested?
- fNIRs-based Neurofeedback
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to Feb 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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".
- Conditions
- Alcohol Use Disorder, Alcoholism, Prescription Drug Dependence, Opioid-use Disorder, Neurofeedback
- Being tested
- fNIRs-based Neurofeedback, Sham feedback
- Keywords
- Prescription Opioid Use Disorder, Alcohol Use Disorder, Functional Near-infrared Spectroscopy, Treatment Outcome, Resisting Craving
- Medical subject headings
- Alcoholism, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group for AUD Patients | Experimental | 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. Receives: Device: fNIRs-based Neurofeedback |
| Sham Feedback Group for AUD Patients | Sham comparator | 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. Receives: Device: Sham feedback |
| Experimental Group for pOUD Patients | Experimental | 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. Receives: Device: fNIRs-based Neurofeedback |
| Sham Feedback Group for pOUD Patients | Sham comparator | 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. Receives: Device: Sham feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: First 90 days after treatment completion at Caron Treatment Center
Secondary outcomes (2)
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
Measured: 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
Measured: First two weeks of protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Jan 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
Why it stopped: Covid-19 related delays made initiation of the project untenable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Grigson, Milton S. Hershey Medical Center
- Investigators
- Patricia S Grigson, PhD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595293
- Sponsor's protocol ID
- 8203
- Status last verified
- Dec 2024
- First submitted
- 29 Jun 2018
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Near Infrared Spectroscopy-based Neurofeedback to Reduce Relapse in Prescription Opioid/Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT03595293
- Acronym / sponsor ID
- 8203
- 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 type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19 related delays made initiation of the project untenable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group for AUD Patients | Experimental | Device: fNIRs-based NeurofeedbackPatients 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. |
| Sham Feedback Group for AUD Patients | Sham comparator | Device: Sham feedbackPatients 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. |
| Experimental Group for pOUD Patients | Experimental | Device: fNIRs-based NeurofeedbackPatients 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. |
| Sham Feedback Group for pOUD Patients | Sham comparator | Device: Sham feedbackPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fNIRs-based NeurofeedbackPatients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area. | Device | Experimental Group for AUD Patients, Experimental Group for pOUD Patients |
| Sham feedbackPatients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area. | Device | Sham Feedback Group for AUD Patients, Sham Feedback Group for pOUD Patients |
Primary outcome
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.
Time frame: First two weeks of protocol
Increase in neural activation in the rDLPFC when viewing alcohol cues from the first neurofeedback session to the sixth (last) session.
Higher levels of abstinence 90-days post-residential treatment completion as assessed by the 7-day timeline followback questionnaires.
Time frame: First 90 days after treatment completion at Caron Treatment Center
7-day timeline followback questionnaire will be sent out every week for 12 weeks to assess abstinence
2 secondary outcomes
Change in self-reported self-efficacy from pre-to-post neurofeedback sessions assessed via the 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.
Time frame: First two weeks of protocol
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia S Grigson, PhD principal investigator
Milton S. Hershey Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing fNIRs-based Neurofeedback in people with Alcohol Use Disorder and Alcoholism, run by Milton S. Hershey Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.