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

Joshua A. Lile, Ph.D.1 site in 1 country2 target enrollmentMarch 1, 2023

ConditionsOpioid Use Disorder

InterventionsDrug Cue Money Withdrawal

DrugsWithdrawal

Overview

Phase: Early Phase 1
Intervention: Drug Cue
Conditions: Opioid Use Disorder
Sponsor: Joshua A. Lile, Ph.D.
Enrollment: 2
Locations: 1
Primary Endpoint: Task choices
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

March 28, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Joshua A. Lile, Ph.D.

Responsible Party

Sponsor Investigator

Principal Investigator

Joshua A. Lile, Ph.D.

Professor

University of Kentucky

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.

Arms & Interventions

Money-vs-money task

Intervention: Drug Cue

Drug-vs-money task

Intervention: Money

Drug-vs-money task

Intervention: Withdrawal

Outcomes

Primary Outcomes

Task choices

Time Frame: Tasks will take approximately 45-60 minutes to complete. Participants will complete 5 sessions in which a choice task will be administered.

Number of choices of each option selected.