31 Participants Needed

Opioid Medications for Opioid Use Disorder

JL
Overseen ByJOSHUA LILE, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a substance use disorder for substances other than opioids or nicotine that requires detoxification, you may not be eligible to participate.

Is oxycodone safe for human use?

Oxycodone, like other opioids, has been associated with risks of misuse, abuse, dependence, and withdrawal. Safety data from studies indicate that abuse-deterrent formulations like Xtampza ER are designed to reduce the potential for misuse, but the risk of dependence and adverse reactions remains, especially when used with other drugs.12345

How does this drug differ from other drugs for opioid use disorder?

This drug may involve the use of opioid medications like methadone, buprenorphine, or naltrexone, which are effective in treating opioid use disorder by managing withdrawal, reducing cravings, and blocking the effects of opioids. What makes these treatments unique is the availability of new formulations, such as monthly depot injections, which can improve adherence and reduce misuse compared to traditional daily dosing.678910

Who Is on the Research Team?

JL

JOSHUA LILE, Ph.D.

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am using an effective form of birth control.
Able to speak and read English
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.
See 1 more

Exclusion Criteria

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.
I don't have any major health or mental issues that would stop me from following the study's requirements.
Contraindications for MRI scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device).
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a gambling task during oxycodone and placebo administration, with an optional remifentanil dose-ranging session for those with a history of IV opioid use

9 days
Inpatient enrollment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Oxycodone
  • Remifentanil
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Placebo treatment followed by active treatmentExperimental Treatment2 Interventions
Group II: Active treatment followed by placebo treatmentExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joshua A. Lile, Ph.D.

Lead Sponsor

Trials
6
Recruited
120+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Published Research Related to This Trial

A significant increase in reports of abuse, misuse, and dependence related to prescription opioids was observed from 2003 to 2018, with 16,506 reports in EudraVigilance and 130,293 in the FDA Adverse Events Reporting System.
Fentanyl and oxycodone were particularly associated with abuse concerns, while tramadol and oxycodone showed stronger links to drug dependence and withdrawal, highlighting the need for careful monitoring by healthcare providers.
Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS).Chiappini, S., Vickers-Smith, R., Guirguis, A., et al.[2022]
Xtampza ER, an abuse-deterrent formulation of extended-release oxycodone, demonstrated significant pain relief in patients with chronic low back pain, showing a mean reduction in pain intensity of -1.56 compared to placebo over 12 weeks.
The study, involving 740 participants, found that Xtampza ER was well tolerated with an adverse event profile similar to other opioids, and it resulted in fewer patients needing rescue medication compared to the placebo group.
A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain.Katz, N., Kopecky, EA., O'Connor, M., et al.[2022]
The abuse-deterrent formulation OxyM-ER (oxycodone myristate extended-release) may not provide effective pain management for cancer patients with low-calorie or low-fat diets, as its efficacy can be influenced by dietary intake.
An interdisciplinary approach, including dietary modifications, can enhance pain control for patients switched to OxyM-ER, demonstrating the importance of considering individual patient circumstances in opioid management.
The Impact of Food on Bioavailability of Oxycodone Myristate: A Case Report.Nguyen, TP., Hagiwara, Y., Pies, C., et al.[2022]

Citations

Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS). [2022]
A phase 3, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability, and efficacy study of Xtampza ER in patients with moderate-to-severe chronic low back pain. [2022]
The Impact of Food on Bioavailability of Oxycodone Myristate: A Case Report. [2022]
Effect of physical manipulation on the oral pharmacokinetic profile of Xtampza® ER (oxycodone DETERx® formulation): A review of published studies. [2020]
Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone. [2020]
A mixed-method comparison of physician-reported beliefs about and barriers to treatment with medications for opioid use disorder. [2021]
Prescription Drug and Alcohol Use Disorders: Opioid Use Disorder. [2019]
Medication Treatment of Opioid Use Disorder. [2021]
Current status of opioid addiction treatment and related preclinical research. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Gaps in Evidence-based Treatment of Concurrent Attention Deficit Hyperactivity Disorder and Opioid Use Disorder: A Scoping Review. [2023]
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