Integrating Brain, Neurocognitive, and Computational Tools in OUD

NCT ID: NCT06136247

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Opioid Use Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

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

Neurocognitive battery

Intervention Type 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

Intervention Type 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 \[35,36\].

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.

Neurocognitive battery

Intervention Type 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

Intervention Type 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 \[35,36\].

Interventions

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Neurocognitive battery

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).

Intervention Type DIAGNOSTIC_TEST

fNIRS

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 \[35,36\].

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Paul Regier, PhD

Role: CONTACT

215-746-3706

Megan Ivey, MS

Role: CONTACT

215-746-7712

Facility Contacts

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Megan Ivey, MS

Role: primary

215-746-7712

Other Identifiers

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854332

Identifier Type: -

Identifier Source: org_study_id

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