Integrating Brain, Neurocognitive, and Computational Tools in OUD

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06136247
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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).
  • 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 \[35,36\].

Study Details

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).

Key Dates

Start date
Nov 1, 2023
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
192 participants (estimated)

Arms

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

Primary Outcome Measure

Drug use [ Time Frame: weeks 1 through 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Megan Ivey, MS
[email protected]
215-746-7712
Paul Regier, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Pennsylvania· Philadelphia, PA

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