Integrating Brain, Neurocognitive, and Computational Tools in OUD

Overseen By Megan Ivey, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

192 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

Men and women who have a moderate to severe addiction to opioids and are taking a stable dose of oral buprenorphine-naloxone or methadone for at least one week.

You must be between 18 and 60 years old to participate.

You can read and understand at an eighth-grade level.

Treatment Details

Participant Groups

Group I: Patients living with Opioid Use Disorder Experimental Treatment 2 Interventions

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

Group II: Healthy controls Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+