Opioid Use Disorder
Conditions
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.
Interventions
DRUGOxycodone
Participants receive oxycodone or placebo.
Sponsors
Joshua A. Lile, Ph.D.
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Within-subjects design
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probabilistic Money vs Money Choice Task | Subjects complete the task twice; once under opioid maintained and once under opioid withdrawn conditions during a 16-day inpatient participation. The task takes approximately 20 minutes to complete each time. | Subjects completed a 300-trial probabilistic concurrent monetary choice task, also known as an n-bandit task (here, n=2 choice options, with unsigned probability reversals every 50 trials). In each trial, subjects chose between two options signaled by blue and green envelopes. When a reward was scheduled for the chosen option, subjects were notified they earned $0.25 USD; task earnings were provided upon session completion. Choice of the high probability option was more likely to be reinforced than the low probability option at a 6:1 ratio, with probabilities summing to 0.3, resulting in a low reinforcement density context. Because choosing the higher probability option is associated with a higher likelihood of receiving a monetary reinforcer, making more high probability choices is considered better performance on the task. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJOSHUA LILE, Ph.D.
University of Kentucky
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 8 / 12 | 11 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed