Using brain and cognitive tools to understand opioid use disorder
Integrating Brain, Neurocognitive, and Computational Tools in Opioid Use Disorder (OUD) to Characterize Executive Function and to Predict Clinical Outcomes.
University of Pennsylvania · NCT06136247
This study is trying to see how opioid use disorder affects thinking and decision-making in people who are stable on medication, to help improve treatment success and prevent relapse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06136247 on ClinicalTrials.gov |
What this trial studies
This observational study aims to integrate brain imaging, neurocognitive assessments, and computational tools like machine learning to explore how opioid use disorder (OUD) affects executive function and treatment outcomes. Over a five-year period, the research will focus on individuals with moderate to severe OUD who are stable on medication. By identifying the impact of co-occurring issues such as depression and anxiety, the study seeks to enhance predictive capabilities for treatment success and relapse prevention. The findings could lead to improved classification of cognitive deficits associated with OUD.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-60 with moderate to severe opioid use disorder who are stable on a prescribed dose of buprenorphine-naloxone or methadone.
Not a fit: Patients with certain severe mental health conditions or those with moderate to severe substance-use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better treatment strategies and outcomes for patients with opioid use disorder.
How similar studies have performed: While the integration of neurocognitive and computational tools in this context is relatively novel, similar studies have shown promise in understanding cognitive deficits in substance use disorders.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Study coordinator: Paul Regier, PhD
- Email: paul.regier@pennmedicine.upenn.edu
- Phone: 215-746-3706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder