Understanding decision-making in people with opioid use disorder

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

This study is trying to see how opioid use and withdrawal impact decision-making in people with opioid use disorder while also figuring out the right dose of a medication for future research.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 31 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT03958474 on ClinicalTrials.gov

What this trial studies

This study aims to explore how opioid use and withdrawal affect decision-making processes through probabilistic reinforcement learning tasks and neuroimaging techniques. It will assess the neurobehavioral and neurobiological mechanisms that contribute to abnormal decision-making in individuals with opioid use disorder. Additionally, the study seeks to determine an appropriate intravenous remifentanil dosage for future research involving physically dependent individuals.

Who should consider this trial

Good fit: Ideal candidates are individuals with moderate to severe opioid use disorder who have a history of intravenous opioid use.

Not a fit: Patients with significant physical or psychiatric conditions that could affect compliance or safety may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and treatment strategies 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 in substance use disorders.

Eligibility criteria

Inclusion Criteria:

* Must meet moderate/severe criteria for moderate/severe opioid use disorder, report recent prescription or illicit opioid use, and be opioid dependent, as evidenced by either a urine sample positive for recent opioid use or being in frank withdrawal during screening.
* 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).
* Able to speak and read English
* Subjects who are interested in completing the remifentanil dose-ranging session must report a history of intravenous opioid use and a baseline O2 saturation of 95% or greater.

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 that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates).
* 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.
* 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.
* Poor venous access (only subjects who will participate in the remifentanil dose-ranging session).

Where this trial is running

Lexington, Kentucky

• Laboratory of Human Behavioral Pharmacology — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: JOSHUA LILE, Ph.D. — University of Kentucky
• Study coordinator: JOSHUA LILE, Ph.D.

Conditions Opioid Use Disorder