Clinical trial NCT03595293: fNIRs-based Neurofeedback to Reduce Relapse in pOUD/AUD
Official title: Functional Near Infrared Spectroscopy-based Neurofeedback to Reduce Relapse in Prescription Opioid/Alcohol Use Disorders
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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".


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: First two weeks of protocol
measure: Increase in fNIRs signal response to pill/alcohol cues from pre-to-post neurofeedback sessions.
timeFrame: First two weeks of protocol
measure: 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
Secondary outcomes:
measure: Change in self-reported self-efficacy from pre-to-post neurofeedback sessions assessed via the brief situational confidence questionnaire.
timeFrame: First two weeks of protocol
measure: Change in self-reported craving from pre-to-post neurofeedback sessions assessed via a 100-point craving visual analog scale.
timeFrame: First two weeks of protocol
Other outcomes:
Locations:
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Patricia S Grigson, PhD
role: PRINCIPAL_INVESTIGATOR
References: