Integrating Brain, Neurocognitive, and Computational Tools in OUD

NCT06136247 | Recruiting

• 1 other identifier: 854332
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (3)

• Drug use

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

  weeks 1 through 8

• Medication adherence

  Patient self report of medication-assisted treatment (MAT) adherence on the weekly Follow Up Survey - days per week having taken their MAT

  weeks 1 through 8

• Mental health symptoms

  Patient self report of mental health symptoms on the weekly Follow Up Survey - days per week of experiencing symptoms of depression or anxiety

  weeks 1 through 8

Study Arms (2)

Healthy controls

Healthy controls, people not living with opioid use disorder or on medication assisted therapy for such.

Diagnostic Test: Neurocognitive battery; Diagnostic Test: fNIRS

Patients living with Opioid Use Disorder

Individuals with opioid use disorder who have been on a stable dose of medication assisted therapy for at least a week.

Diagnostic Test: Neurocognitive battery; Diagnostic Test: fNIRS

Interventions

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).

Healthy controls; Patients living with Opioid Use Disorder

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 \[35,36\].

Healthy controls; Patients living with Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

96 individuals living with OUD and on stable MAT, as well as 96 individuals who are considered healthy controls, all living in the greater Philadelphia area and able to attend study visits at the University of Pennsylvania.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Paul Regier, PhD

CONTACT

215-746-3706; paul.regier@pennmedicine.upenn.edu

Megan Ivey, MS

CONTACT

215-746-7712; megan.ivey@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)