NCT06136247 Integrating Brain, Neurocognitive, and Computational Tools in OUD
| NCT ID | NCT06136247 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Opioid Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 192 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 192 participants in total. It began in 2023-11-01 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06136247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06136247 currently recruiting?
Yes, NCT06136247 is actively recruiting participants. Contact the research team at paul.regier@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06136247 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06136247 clinical trial?
NCT06136247 is sponsored by University of Pennsylvania. The trial plans to enroll 192 participants.