Alcohol Use Disorder, Alcoholism, Prescription Drug Dependence, Opioid-use Disorder, Neurofeedback
Conditions
Keywords
Prescription Opioid Use Disorder, Alcohol Use Disorder, Functional Near-infrared Spectroscopy, Treatment Outcome, Resisting Craving
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.
Interventions
Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.
DEVICESham feedback
Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions. | 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-reported self-efficacy from pre-to-post neurofeedback sessions assessed via the brief situational confidence questionnaire. | First two weeks of protocol | Before and after each neurofeedback session, participants will complete a brief situational confidence questionnaire |
| Change in self-reported craving from pre-to-post neurofeedback sessions assessed via a 100-point craving visual analog scale. | First two weeks of protocol | Before and after each neurofeedback session, participants will complete a 100-point craving visual analog scale |
Outcome results
None listed