Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06136247

Integrating Brain, Neurocognitive, and Computational Tools in OUD

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Megan Ivey, MS

CONTACT

[email protected]

215-746-7712

Paul Regier, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neurocognitive battery

Diagnostic Test

The Penn Computerized Neurobehavioral Battery (CNB) consists of a series of cognitive tasks, measuring accuracy and speed of performance in major cognitive domains, including executive functions (i.e., abstraction, sustained attention, working memory), episodic memory (i.e., verbal, facial, and spatial memory), complex cognitive processing (i.e., language reasoning, nonverbal reasoning, spatial processing), social cognition (i.e., emotion identification, emotion intensity differentiation, age differentiation) and processing speed (i.e., sensorimotor and motor).

fNIRS

Diagnostic Test

Functional near-infrared spectroscopy (fNIRS) is a noninvasive optical imaging technique that measures changes in oxygenated and deoxygenated hemoglobin (Hb) concentrations within the brain by means of their characteristic absorption spectra of the wavelengths range of 700-1000 nm [35,36].

Primary outcomes

  1. Drug use

    Time frame: weeks 1 through 8

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

  2. Medication adherence

    Time frame: 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

  3. Mental health symptoms

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Ivey, MS

CONTACT

[email protected]

215-746-7712

Paul Regier, PhD

CONTACT

[email protected]

215-746-3706

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.