Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice

Opioid Use Disorder Clinical Trial

— BED(In)(44)  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312657
• Other study ID #: 81971
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 1, 2024
• Est. completion date: March 28, 2026

Study information

• Verified date: April 2024
• Source: University of Kentucky
• Contact: Joshua Lile, Ph.D.
• Phone: 8593236034
• Email: jalile2[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: March 28, 2026
• Est. primary completion date: March 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• Drug Cue
Individualized drug cues paired with choice options reinforced by $0.25
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Joshua A. Lile, Ph.D.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Task choices	Number of choices of each option selected.	Tasks will take approximately 45-60 minutes to complete. Participants will complete 5 sessions in which a choice task will be administered.