Understanding decision-making in people with opioid use disorder

Behavioral Effects of Drugs Inpatient 44: Neurobehavioral Mechanisms of Opioid Choice

This study is trying to understand how people with opioid use disorder make decisions by looking at their brain activity and responses to different rewards and drug cues.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Kentucky (other)
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT06312657 on ClinicalTrials.gov

What this trial studies

This study aims to explore the neurobehavioral mechanisms behind decision-making in individuals with opioid use disorder through the use of probabilistic choice tasks, reinforcement learning modeling, and functional MRI (fMRI). Participants will be assessed for their responses to drug cues, monetary incentives, and withdrawal symptoms. The research focuses on individuals who are physically dependent on short-acting opioids and have a history of intravenous use. By analyzing brain activity and decision-making patterns, the study seeks to uncover insights that could inform treatment strategies for opioid use disorder.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18-50 with moderate to severe opioid use disorder who are physically dependent on short-acting opioids.

Not a fit: Patients with significant physical diseases or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and treatment options for individuals struggling with opioid use disorder.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding decision-making processes in substance use disorders.

Eligibility criteria

Inclusion Criteria:

* Individuals must meet criteria for moderate/severe opioid use disorder, report past month opioid misuse, and be physically dependent on short-acting opioids (e.g., heroin, hydromorphone, fentanyl), as evidenced by either urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening.
* History of intravenous opioid use.
* Baseline O2 saturation of 95% or greater.
* Between the ages of 18-50 years.
* Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.
* Able to speak and read English.
* Otherwise healthy.

Exclusion Criteria:

* History of, or current, clinically significant physical disease (e.g., respiratory disease \[asthma, COPD, sleep apnea\], impaired cardiovascular functioning, seizure disorder or CNS tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder.
* Meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (OUD subjects only) or nicotine/caffeine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). Negative urine/breath samples for these substances, and the absence of withdrawal, will be required during screening.
* Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).
* Vision or hearing problems that would preclude completion of experimental tasks.
* Poor venous access.
* Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins or short-term antibiotic prescriptions.
* At risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed.
* Seeking treatment for SUD or currently taking buprenorphine or methadone as the primary opioid of use.

Where this trial is running

Lexington, Kentucky

• University of Kentucky — Lexington, Kentucky, United States (RECRUITING)

Study contacts

• Study coordinator: Joshua Lile, Ph.D.

Conditions: Opioid Use Disorder