Alcohol Use Disorder Clinical Trial
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".
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Milton S. Hershey Medical Center |
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 |
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