Clinical trial Recruiting at 1 site Observational Ages 18 to 60

Using brain and cognitive tools to understand opioid use disorder

Official title: Integrating Brain, Neurocognitive, and Computational Tools in Opioid Use Disorder (OUD) to Characterize Executive Function and to Predict Clinical Outcomes.

Run by University of Pennsylvania · NCT06136247 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 60 Years
SexAll
Enrollment192 (estimated)
SponsorUniversity of Pennsylvania
Academic / other
Locations1 site (Philadelphia, Pennsylvania)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedJanuary 31, 2027
Study endsJuly 31, 2027
Registry record updatedDecember 4, 2025
Trial IDNCT06136247 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.