Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice

NCT06312657 | Terminated Early Phase 1 Results FDA Drug

• 2 other identifiers: 81971R01DA047368
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this protocol is to use probabilistic choice tasks to determine the impact of withdrawal and drug cues on decision-making in individuals with opioid use disorder and physical opioid dependence.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (1)

• Task Choices

  Proportion of high probability choices. Subjects can choose between two options, one of which is rewarded at a higher probability than the other at a ratio of 6:1. The number of trials varied, so a proportion of total trials is reported.

  Tasks will take approximately 45-60 minutes to complete. Participants will complete 6 sessions in which a choice task will be administered.

Study Arms (1)

Probabilistic Choice Task

EXPERIMENTAL

Subjects with opioid use disorder complete a probabilistic concurrent choice task under opioid maintained and withdrawn conditions. Three sessions include a money-vs-money task and three sessions include a drug-vs-money task. Monetary reward value is $0.25 or $4.00. Task option visual cues for the money-vs-money versions are colored envelopes or opioid-associated and matched neutral cues. Drug is an active dose of remifentanil.

Behavioral: Drug Cue; Behavioral: Money; Drug: Withdrawal; Drug: Remifentanil

Interventions

Drug Cue BEHAVIORAL

Individualized drug cues paired with choice options reinforced by $0.25

Probabilistic Choice Task

Money BEHAVIORAL

Two money values will be tested ($0.25 and $4.00)

Probabilistic Choice Task

Withdrawal DRUG

Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal.

Probabilistic Choice Task

Remifentanil DRUG

IV remifentanil will be made available as one of the choice options in some sessions.

Probabilistic Choice Task

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joshua A. Lile, Ph.D.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Joshua Lile, PhD
• Organization: University of Kentucky

jalile2@uky.edu

859-323-6034

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 1, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)