Clinical trial NCT06312657: Behavioral Effects of Drugs Inpatient 44 Neurobehavioral Mechanisms of Opioid Choice
Official title: Behavioral Effects of Drugs Inpatient 44: Neurobehavioral Mechanisms of Opioid Choice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Opioid Use Disorder
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-15
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Task choices
timeFrame: Tasks will take approximately 45-60 minutes to complete. Participants will complete 5 sessions in which a choice task will be administered.
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References: