Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03595293
Other study ID # 8203
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04788004 - Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
Recruiting NCT05684094 - Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function N/A
Completed NCT03406039 - Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems N/A
Completed NCT03573167 - Mobile Phone-Based Motivational Interviewing in Kenya N/A
Completed NCT04817410 - ED Initiated Oral Naltrexone for AUD Phase 1
Active, not recruiting NCT04267692 - Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders N/A
Completed NCT03872128 - The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders Phase 1
Completed NCT02989662 - INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers Phase 1/Phase 2
Recruiting NCT06030154 - Amplification of Positivity for Alcohol Use N/A
Active, not recruiting NCT05419128 - Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19 N/A
Completed NCT04564807 - Testing an Online Insomnia Intervention N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04203966 - Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
Recruiting NCT05861843 - Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
Terminated NCT04404712 - FAAH Availability in Psychiatric Disorders: A PET Study Early Phase 1
Enrolling by invitation NCT04128761 - Decreasing the Temporal Window in Individuals With Alcohol Use Disorder N/A
Not yet recruiting NCT06444243 - Psilocybin-assisted Therapy for Alcohol Use Disorder Phase 2
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06337721 - Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults N/A
Enrolling by invitation NCT02544581 - Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare N/A