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Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

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ClinicalTrials.gov Identifier: NCT03958474
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua A. Lile, Ph.D., University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder Drug: Oxycodone Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Within-subjects design
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Basic Science
Official Title: Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
Actual Study Start Date : August 16, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Gambling task [ Time Frame: 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 ]
    The number of monetary rewards earned on a gambling task, in which two options signaled by distinct cues are presented on a computer screen and choosing either could result in the delivery of money, but the reinforcement probabilities of the options differ, and change during the task.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958474


Contacts
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Contact: JOSHUA LILE, Ph.D. 8593236034 jalile2@uky.edu

Locations
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United States, Kentucky
Laboratory of Human Behavioral Pharmacology Recruiting
Lexington, Kentucky, United States, 40536-0086
Contact: Frances Wagner, RN    859-257-5388    fpwagn2@uky.edu   
Principal Investigator: Joshua A. Lile, Ph.D.         
Sponsors and Collaborators
Joshua A. Lile, Ph.D.
Investigators
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Principal Investigator: JOSHUA LILE, Ph.D. University of Kentucky

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Responsible Party: Joshua A. Lile, Ph.D., Associate Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03958474     History of Changes
Other Study ID Numbers: 47844
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents