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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

Must not have

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.

Vision or hearing problems that would preclude completion of experimental tasks.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured continuously during a single 2.5 hour session in which remifentanil is administered.

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I am using an effective form of birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I don't have any major health or mental issues that would stop me from following the study's requirements.

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I do not have vision or hearing problems that would stop me from completing study tasks.

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I have a substance use disorder needing detox, not including opioids or nicotine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured continuously during a single 2.5 hour session in which remifentanil is administered.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gambling task

Secondary study objectives

End tidal carbon dioxide

Oxygen saturation

Respiration rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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