Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

NCT ID: NCT03958474

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-16
• Study Completion Date: 2025-07-10

Brief Summary

The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Active treatment followed by placebo treatment

Participants complete a gambling task during oxycodone administration and then complete the same gambling task during placebo administration. Participants with a history of IV opioid use can opt to complete a final remifentanil dose-ranging session.

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

Participants receive oxycodone or placebo.

Remifentanil

Intervention Type: DRUG

Participants with a history of IV opioid use can opt to complete a session in which they receive remifentanil.

Placebo treatment followed by active treatment

Participants complete a gambling task during placebo administration and then complete the same gambling task during oxycodone administration. Participants with a history of IV opioid use can opt to complete a final remifentanil dose-ranging session.

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

Participants receive oxycodone or placebo.

Remifentanil

Intervention Type: DRUG

Participants with a history of IV opioid use can opt to complete a session in which they receive remifentanil.

Interventions

Oxycodone

Participants receive oxycodone or placebo.

Intervention Type: DRUG

Remifentanil

Participants with a history of IV opioid use can opt to complete a session in which they receive remifentanil.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Joshua A. Lile, Ph.D.

OTHER

Sponsor Role: lead

Responsible Party

Joshua A. Lile, Ph.D.

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

JOSHUA LILE, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DA047368

Identifier Type: NIH

Identifier Source: secondary_id

View Link

47844

Identifier Type: -

Identifier Source: org_study_id