COMPLETED

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

Quick Facts

Study Start:2019-08-16

Study Completion:2025-07-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT03958474

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Principal Investigator

JOSHUA LILE, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Kentucky

Study Locations (Sites)

Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, 40536-0086

United States

Collaborators and Investigators

Sponsor: Joshua A. Lile, Ph.D.

JOSHUA LILE, Ph.D., PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-16

Study Completion Date2025-07-10

Study Record Updates

Study Start Date2019-08-16

Study Completion Date2025-07-10

Terms related to this study

Additional Relevant MeSH Terms

Opioid Use Disorder