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Opioid Medications for Opioid Use Disorder

Phase < 1
Recruiting
Led By JOSHUA LILE, Ph.D.
Research Sponsored by Joshua A. Lile, Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured continuously during a single 2.5 hour session in which remifentanil is administered.
Awards & highlights

Study Summary

This trial is meant to study how opioid use and withdrawal affects people's decision-making, and to look for ways to help those with opioid addiction.

Who is the study for?
This trial is for adults with moderate to severe opioid use disorder who have used opioids recently or are in withdrawal. They must speak English and, if female, use effective birth control. It excludes those with other substance disorders needing detox (except nicotine), MRI contraindications, respiratory risks, seeking SUD treatment, poor veins (for remifentanil session), significant diseases or psychiatric disorders affecting compliance.Check my eligibility
What is being tested?
The study tests how opioid dependency and withdrawal affect decision-making using tasks and brain imaging. It aims to understand the related neurobehavioral processes and find a suitable dose of intravenous remifentanil for future research on individuals dependent on opioids.See study design
What are the potential side effects?
Potential side effects from Oxycodone and Remifentanil may include nausea, drowsiness, constipation, confusion, respiratory depression (slowed breathing), addiction potential as well as tolerance development leading to increased dosage requirements over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using an effective form of birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured continuously during a single 2.5 hour session in which remifentanil is administered.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured continuously during a single 2.5 hour session in which remifentanil is administered. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gambling task
Secondary outcome measures
End tidal carbon dioxide
Oxygen saturation
Respiration rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo treatment followed by active treatmentExperimental Treatment2 Interventions
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.
Group II: Active treatment followed by placebo treatmentExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone
2014
Completed Phase 4
~2210
Remifentanil
2019
Completed Phase 4
~1610

Find a Location

Who is running the clinical trial?

Joshua A. Lile, Ph.D.Lead Sponsor
5 Previous Clinical Trials
93 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,496 Previous Clinical Trials
2,623,874 Total Patients Enrolled
JOSHUA LILE, Ph.D.Principal InvestigatorUniversity of Kentucky

Media Library

Remifentanil Clinical Trial Eligibility Overview. Trial Name: NCT03958474 — Phase < 1
Opioid Use Disorder Research Study Groups: Active treatment followed by placebo treatment, Placebo treatment followed by active treatment
Opioid Use Disorder Clinical Trial 2023: Remifentanil Highlights & Side Effects. Trial Name: NCT03958474 — Phase < 1
Remifentanil 2023 Treatment Timeline for Medical Study. Trial Name: NCT03958474 — Phase < 1
~4 spots leftby Mar 2025
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