Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice

Launched by JOSHUA A. LILE, PH.D. · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how people with opioid use disorder make decisions when it comes to drug use. Researchers want to understand the brain processes involved in choosing opioids and how these choices are influenced by different factors. They will use special tasks and brain imaging techniques to explore these decision-making mechanisms.

To participate, individuals must be between 18 and 50 years old, have a moderate to severe opioid use disorder, and show physical dependence on short-acting opioids, like heroin or fentanyl. Participants will need to be able to read and speak English, and women must use effective birth control. During the study, participants can expect to complete tasks while undergoing brain scans. It's important to note that certain health conditions or other substance use may prevent someone from joining this trial. This research aims to help improve understanding and treatment options for those struggling with opioid addiction.

Gender

ALL

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.