Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
Purpose
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.
Condition
- Opioid Use Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- All
- Accepts 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).
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Within-subjects design
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- Double-blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Active treatment followed by placebo treatment |
Participants complete a gambling task during oxycodone administration and then complete the same gambling task during placebo administration. Participants with a history of IV opioid use can opt to complete a final remifentanil dose-ranging session. |
|
|
Experimental Placebo treatment followed by active treatment |
Participants complete a gambling task during placebo administration and then complete the same gambling task during oxycodone administration. Participants with a history of IV opioid use can opt to complete a final remifentanil dose-ranging session. |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky 40536-0086
Lexington, Kentucky 40536-0086
More Details
- NCT ID
- NCT03958474
- Status
- Recruiting
- Sponsor
- Joshua A. Lile, Ph.D.