Integrating Brain, Neurocognitive, and Computational Tools in OUD

Last updated: November 25, 2024
Sponsor: University of Pennsylvania
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

fNIRS

Neurocognitive battery

Clinical Study ID

NCT06136247
854332
  • Ages 18-60
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • men and women with moderate to severe opioid use disorder by Diagnostic andStatistical Manual, version 5, (DSM-V) criteria on a stable (at least one weekwithout 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

Exclusion Criteria:

  • unable to understand or complete the tasks.

  • Certain mental health conditions, including (but not limited to) bipolar I withcurrent manic episode, schizophrenia, and schizoaffective disorder, determined bythe Principal Investigator (PI) to interfere with study participation.

  • moderate or severe substance-use disorder (for Healthy Controls)

Study Design

Total Participants: 192
Treatment Group(s): 2
Primary Treatment: fNIRS
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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