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Opioid Analgesic

Opioid Mechanisms for Stress Management

Q: What ailments typically respond best to this therapy?

<p>This treatment can ameliorate <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, both acute and moderate in nature, as well as opioid-related discomfort.</p>

N/A

Recruiting

Led By Stephen Bruehl, PhD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity

Intact cognitive status and ability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up across 3 laboratory assessment days (an expected average of 15 day period)

Awards & highlights

Study Summary

This trial will help researchers learn more about how stress affects the way our bodies process pain medication.

Who is the study for?

This trial is for adults over 18 with persistent low back pain lasting at least three months and averaging at least a moderate intensity. Participants must be cognitively intact, able to consent, and proficient in English. Excluded are those who've used opioids or benzodiazepines recently, have significant health issues like heart disease, are pregnant, have kidney or liver problems, a history of substance abuse treatment, chronic pain from cancer/autoimmune diseases, allergies to oxycodone or similar drugs, or certain psychiatric disorders.Check my eligibility

What is being tested?

The study examines the impact of stress on the risk of misusing opioid medications prescribed for chronic back pain relief. It involves testing Oxycodone (a pain reliever), Naloxone (which can block opioid effects), and a placebo to understand how stress might affect their use and potential misuse.See study design

What are the potential side effects?

Oxycodone may cause drowsiness, constipation, nausea/vomiting; it also has a risk for dependency or addiction. Naloxone can trigger withdrawal symptoms in people dependent on opioids. Placebos typically do not cause side effects but can lead to perceived symptoms due to expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had daily lower back pain for at least three months, with a pain level of at least 3 out of 10.

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I understand information and can make decisions about my health care.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ across 3 laboratory assessment days (an expected average of 15 day period)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~across 3 laboratory assessment days (an expected average of 15 day period)

This trial's timeline: 3 weeks for screening, Varies for treatment, and across 3 laboratory assessment days (an expected average of 15 day period) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite measure of changes in MPQ-2 ratings of low back pain from the placebo to naloxone condition (standardized) plus plasma levels of endocannabinoids (standardized)

Mean DELTA Drug Liking subscale scores in the oxycodone condition

Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to oxycodone condition

Secondary outcome measures

DELTA Take Again subscale scores in the oxycodone condition

Mean Delta Effects subscale in the oxycodone condition

Mean VAS Opioid Euphoria subscale in the oxycodone condition

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adults with chronic non-cancer low back painExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxycodone

2014

Completed Phase 4

~2210

Naloxone

2014

Completed Phase 3

~1240

Placebo

1995

Completed Phase 3

~2670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,468 Previous Clinical Trials

2,619,228 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,072 Total Patients Enrolled

Stephen Bruehl, PhDPrincipal InvestigatorVanderbilt University Medical Center

2 Previous Clinical Trials

357 Total Patients Enrolled

Media Library

Oxycodone (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05142267 — N/A

Opioid Use Disorder Research Study Groups: Adults with chronic non-cancer low back pain

Opioid Use Disorder Clinical Trial 2023: Oxycodone Highlights & Side Effects. Trial Name: NCT05142267 — N/A

Oxycodone (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142267 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended goal of this investigation?

"This trial, to be assessed over a span of 15 days, sets out to evaluate the Mean DELTA Drug Liking subscale scores in the oxycodone condition. Secondary goals include assessing mean changes in MPQ-2 ratings from placebo to oxycodone for both heat and ischemic task pain (scores range from 0-10 where higher numbers indicate greater intensity). Lastly, this study intends on measuring Delta Effects subscale ratings post intervention using a 1-5 scale with 5 representing strong effects."

Answered by AI

What ailments typically respond best to this therapy?

"This treatment can ameliorate pain, both acute and moderate in nature, as well as opioid-related discomfort."

Answered by AI

What other clinical experiments have assessed the efficacy of this particular treatment?

"Currently, there are 61 active investigations into this treatment with 14 studies in their third phase. Durham, North carolina is hosting several of these trials while 146 different medical centres across the country have set up clinical trial programs for it."

Answered by AI

What is the enrollment number for this clinical research trial?

"Affirmative. Clinicaltrials.gov attests that this medical trial opened up to candidates on the 2nd of March 2022 and was modified as recently as 4th of March, with an aim to acquire 120 test subjects at a single study site."

Answered by AI

Are there any opportunities for individuals to take part in this research endeavor?

"Yes, the information on clinicaltrials.gov confirms that this study is presently recruiting. This medical trial was first announced in March 2nd 2022 and has since had a minor update; researchers are searching for 120 volunteers to participate at one location."

Answered by AI