Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice

NCT ID: NCT06312657

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-03-28

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.

Conditions

Opioid Use Disorder

Study Design

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

Study Groups

Money-vs-money task

Group Type: EXPERIMENTAL

Drug Cue

Intervention Type: BEHAVIORAL

Individualized drug cues paired with choice options reinforced by $0.25

Drug-vs-money task

Group Type: EXPERIMENTAL

Money

Intervention Type: BEHAVIORAL

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

Withdrawal

Intervention Type: DRUG

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

Interventions

Drug Cue

Individualized drug cues paired with choice options reinforced by $0.25

Intervention Type: BEHAVIORAL

Money

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

Intervention Type: BEHAVIORAL

Withdrawal

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

Intervention Type: DRUG

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.

• 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

Locations

University of Kentucky

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

81971

Identifier Type: -

Identifier Source: org_study_id