Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice (BED(In)(44))

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

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.

Study Overview

• Status: Terminated
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Behavioral: Drug Cue; Behavioral: Money; Drug: Withdrawal; Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Probabilistic Choice Task; 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; Individualized drug cues paired with choice options reinforced by $0.25; Behavioral: Money; Two money values will be tested ($0.25 and $4.00); Drug: Withdrawal; Participants will be maintained on an opioid agonist. Placebo will be substituted to produce mild-to-moderate withdrawal.; Drug: Remifentanil; IV remifentanil will be made available as one of the choice options in some sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acids, Acyclic; Carboxylic Acids; Piperidines; Propionates; Remifentanil
• Other Study ID Numbers: 81971; R01DA047368 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No