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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.

Condition

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

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.

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

ArmDescriptionAssigned 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.
  • Drug: Oxycodone
    Participants receive oxycodone or placebo.
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.
  • Drug: Oxycodone
    Participants receive oxycodone or placebo.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky 40536-0086
Contact:
Frances Wagner, RN
859-257-5388
fpwagn2@uky.edu

More Details

NCT ID
NCT03958474
Status
Recruiting
Sponsor
Joshua A. Lile, Ph.D.

Study Contact

JOSHUA LILE, Ph.D.
8593236034
jalile2@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.