Understanding Opioid Use Disorder and Brain Function

This observational study is looking at how opioid use disorder (OUD) affects brain function and treatment outcomes. Researchers will use special tests like a neurocognitive battery (a series of thinking tasks) and fNIRS (functional near-infrared spectroscopy, a non-invasive way to measure brain activity) to understand these effects. You might be able to join if you are 18-60 years old, speak English, can read at an eighth-grade level, and have moderate to severe OUD. You also need to be on a stable dose of buprenorphine-naloxone or methadone. The study aims to understand how brain function relates to drug use, how well you stick to your medication, and your mental health symptoms over 8 weeks. The study plans to enroll 192 participants, but its current recruitment status is unclear.

Study design
This is an observational study planning to enroll 192 participants. It will use diagnostic tests to understand the impact of opioid use disorder.
What's involved
You would undergo neurocognitive battery tests and fNIRS brain scans. The study will track drug use, medication adherence, and mental health symptoms for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for drug use, medication adherence, and mental health symptoms for 8 weeks.

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NCT06136247

Integrating Brain, Neurocognitive, and Computational Tools in OUD

Recruiting
Not specifiedAges 18–60Observational
University of Pennsylvania
~192 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Neurocognitive batteryfNIRS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Drug use
Measured over weeks 1 through 8
+2 more outcomes measured
Opioid Use Disorder
1 sites across 1 states
Pennsylvania1

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Eligibility criteria

Inclusion

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

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)
  • Drug useweeks 1 through 8

    Patient self report of drug use on the weekly Follow Up Survey- days per week having taken any drugs

  • Medication adherenceweeks 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

  • Mental health symptomsweeks 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