Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958474
• Other study ID #: 47844
• Secondary ID: R01DA047368
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 16, 2019
• Est. completion date: March 30, 2025

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: JOSHUA LILE, Ph.D.
• Phone: 8593236034
• Email: jalile2[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• Oxycodone
Participants receive oxycodone or placebo.
• Remifentanil
Participants with a history of IV opioid use can opt to complete a session in which they receive remifentanil.

Locations

Country	Name	City	State
United States	Laboratory of Human Behavioral Pharmacology	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Joshua A. Lile, Ph.D.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gambling task	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.	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
Secondary	Respiration rate	Breaths per minute measured by capnography device	Measured continuously during a single 2.5 hour session in which remifentanil is administered.
Secondary	End tidal carbon dioxide	End tidal carbon dioxide measured by capnography device	Measured continuously during a single 2.5 hour session in which remifentanil is administered.
Secondary	Oxygen saturation	Blood oxygen concentration measured by capnography device	Measured continuously during a single 2.5 hour session in which remifentanil is administered.