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Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

Primary Purpose

Opioid Use Disorder

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxycodone
Remifentanil
Sponsored by
Joshua A. Lile, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Laboratory of Human Behavioral PharmacologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active treatment followed by placebo treatment

Placebo treatment followed by active treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Respiration rate
Breaths per minute measured by capnography device
End tidal carbon dioxide
End tidal carbon dioxide measured by capnography device
Oxygen saturation
Blood oxygen concentration measured by capnography device

Full Information

First Posted
May 16, 2019
Last Updated
January 10, 2023
Sponsor
Joshua A. Lile, Ph.D.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03958474
Brief Title
Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
Official Title
Neurobehavioral Mechanisms of Choice in Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2019 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua A. Lile, Ph.D.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. A second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Model Description
Within-subjects design
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active treatment followed by placebo treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo treatment followed by active treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Participants receive oxycodone or placebo.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
Participants with a history of IV opioid use can opt to complete a session in which they receive remifentanil.
Primary Outcome Measure Information:
Title
Gambling task
Description
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.
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
Secondary Outcome Measure Information:
Title
Respiration rate
Description
Breaths per minute measured by capnography device
Time Frame
Measured continuously during a single 2.5 hour session in which remifentanil is administered.
Title
End tidal carbon dioxide
Description
End tidal carbon dioxide measured by capnography device
Time Frame
Measured continuously during a single 2.5 hour session in which remifentanil is administered.
Title
Oxygen saturation
Description
Blood oxygen concentration measured by capnography device
Time Frame
Measured continuously during a single 2.5 hour session in which remifentanil is administered.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JOSHUA LILE, Ph.D.
Phone
8593236034
Email
jalile2@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JOSHUA LILE, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Human Behavioral Pharmacology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0086
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Wagner, RN
Phone
859-257-5388
Email
fpwagn2@uky.edu
First Name & Middle Initial & Last Name & Degree
Joshua A. Lile, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurobehavioral Mechanisms of Choice in Opioid Use Disorder

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