Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT06312657

Run by

Joshua A. Lile, Ph.D.

People needed

2

Starts

2023-03-01

Expected to finish

2025-03-28

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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