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Opioid Analgesic

Opioid Mechanisms for Stress Management

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 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
Placebo
1995
Completed Phase 3
~2670
Naloxone
2014
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,497 Previous Clinical Trials
2,623,703 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
866 Previous Clinical Trials
672,447 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
~52 spots leftby Mar 2026
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