Opioid Use Disorder Clinical Trials

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Integrating Brain, Neurocognitive, and Computational Tools in Opioid Use Disorder (OUD) to Characterize Executive Function and to Predict Clinical Outcomes.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
View:

• 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.

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Paul Regier, PhD
paul.regier@pennmedicine.upenn.edu
215-746-3706
Backup
Megan Ivey, MS
megan.ivey@pennmedicine.upenn.edu
215-746-7712
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 192
Treatments
Healthy controls
Healthy controls, people not living with opioid use disorder or on medication assisted therapy for such.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov