Integrating Brain, Neurocognitive, and Computational Tools in OUD
- Conditions
- Opioid Use Disorder
- Interventions
- Diagnostic Test: Neurocognitive batteryDiagnostic Test: fNIRS
- Registration Number
- NCT06136247
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
The 5-year K01 Mentored Research Scientist proposal will employ brain, neurocognitive, and computational tools (e.g., machine learning) to understand the impact of opioid-use disorder (OUD) and common co-occurring issues on executive function and clinical outcomes. There have been record numbers of fatal and non-fatal overdoses (ODs) associated with opioids (and other drugs) in the past 12-months. Improving classification and predictive capabilities to enhance treatment and prevent relapse is of the upmost importance. Deficits in neurocognition often are associated with poor treatment outcomes (e.g., more drug use, medication non-adherence), yet co-occurring issues associated with OUD (e.g., depression, anxiety, physical/sexual abuse, neglect) make it difficult to parse which contributing factors lead to worse executive function (EF) and poorer treatment outcomes. Novel brain, neurocognitive, and computational tools are needed to help determine these differences, in order to lay the foundation for better treatments. This need has shaped both the training plan and the associated research project in a 5-year K01 Mentored Research Scientist proposal, building on Dr. Regier's prior preclinical and clinical addiction neuroscience experience (focused mostly on cocaine-use disorders, cue-reactivity, subcortical networks, prior adversity, and univariate imaging techniques).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 192
- men and women with moderate to severe opioid use disorder by Diagnostic and Statistical Manual, version 5, (DSM-V) criteria on a stable (at least one week without change) dose of oral buprenorphine-naloxone or methadone. (for OUD group)
- Eligible participants will be between 18-60 years of age;
- able to read at an eighth-grade level;
- able to speak English.
- unable to understand or complete the tasks.
- Certain mental health conditions, including (but not limited to) bipolar I with current manic episode, schizophrenia, and schizoaffective disorder, determined by the Principal Investigator (PI) to interfere with study participation.
- moderate or severe substance-use disorder (for Healthy Controls)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy controls fNIRS Healthy controls, people not living with opioid use disorder or on medication assisted therapy for such. Healthy controls Neurocognitive battery Healthy controls, people not living with opioid use disorder or on medication assisted therapy for such. Patients living with Opioid Use Disorder Neurocognitive battery Individuals with opioid use disorder who have been on a stable dose of medication assisted therapy for at least a week. Patients living with Opioid Use Disorder fNIRS Individuals with opioid use disorder who have been on a stable dose of medication assisted therapy for at least a week.
- Primary Outcome Measures
Name Time Method Mental health symptoms weeks 1 through 8 Patient self report of mental health symptoms on the weekly Follow Up Survey - days per week of experiencing symptoms of depression or anxiety
Medication adherence weeks 1 through 8 Patient self report of medication-assisted treatment (MAT) adherence on the weekly Follow Up Survey - days per week having taken their MAT
Drug use weeks 1 through 8 Patient self report of drug use on the weekly Follow Up Survey- days per week having taken any drugs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States