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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

Must not have

Chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., rheumatoid arthritis, lupus)

Reported daily opiate use within the past 6 months, or use of any opioid analgesic medications within 3 days of study participation (confirmed through rapid urine screening prior to each lab session)

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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.

Exclusion Criteria

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

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I have chronic pain from cancer or an autoimmune disease like rheumatoid arthritis or lupus.

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I have used opioids daily in the past 6 months or within 3 days before joining the study.

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I have had kidney or liver problems in the past.

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I have recently used benzodiazepines, confirmed by a urine test.

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

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

Primary study objectives

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 study objectives

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

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