Clinical trial NCT03958474: Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
Official title: Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
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: 2019-05-22
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Within-subjects design
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.


Eligibility criteria: Inclusion Criteria:

* Must meet moderate/severe criteria for moderate/severe opioid use disorder, report recent prescription or illicit opioid use, and be opioid dependent, as evidenced by either a urine sample positive for recent opioid use or being in frank withdrawal during screening.
* 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).
* Able to speak and read English
* Subjects who are interested in completing the remifentanil dose-ranging session must report a history of intravenous opioid use and a baseline O2 saturation of 95% or greater.

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 that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates).
* 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.
* 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.
* Poor venous access (only subjects who will participate in the remifentanil dose-ranging session).

Primary outcomes:
measure: Gambling task
timeFrame: Change in monetary rewards earned on a gambling task as a function of the intervention will be assessed by administering this task once per session across two sessions during a 9-day inpatient enrollment in each subject
Secondary outcomes:
measure: Respiration rate
timeFrame: Measured continuously during a single 2.5 hour session in which remifentanil is administered.
measure: End tidal carbon dioxide
timeFrame: Measured continuously during a single 2.5 hour session in which remifentanil is administered.
measure: Oxygen saturation
timeFrame: Measured continuously during a single 2.5 hour session in which remifentanil is administered.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Laboratory of Human Behavioral Pharmacology
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: JOSHUA LILE, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: