Opioid Mechanisms for Stress Management
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to see how stress influences the effects of opioid pain medications often used to help relieve back pain. The study will help to learn more about how high stress levels could increase risk for pain medication misuse.
Will I have to stop taking my current medications?
The trial requires that you have not used any opioid pain medications within 3 days of participating in the study. If you are currently using opioids, you will need to stop taking them at least 3 days before joining the trial.
Is oxycodone generally safe for human use?
Oxycodone is a widely used pain medication that has been studied extensively for its safety and effectiveness. Common side effects include nausea, constipation, and drowsiness, which often decrease over time. It has a potential for abuse, similar to other opioids, and should be used under medical supervision.12345
How does the drug Oxycodone work for stress management?
Oxycodone is unique for stress management because it acts on multiple opioid receptors in the brain, which can help modulate stress-related behaviors and reduce the risk of developing conditions like PTSD by inhibiting fear-related memory consolidation. Unlike other treatments, it specifically targets the opioid system to manage stress responses, which is not a standard approach for stress management.36789
What data supports the effectiveness of the drug for stress management?
Research shows that oxycodone, a component of the drug, is effective in managing severe pain, which may indirectly help with stress by alleviating pain-related stressors. Additionally, the combination of oxycodone with naloxone has been used to manage chronic pain, suggesting potential benefits in stress management through pain relief.24101112
Who Is on the Research Team?
Stephen Bruehl, PhD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline assessment of stress-related markers
Treatment
Participants undergo 3 laboratory sessions with assessments of endocannabinoids, back pain, and exposure to pain stimuli after administration of placebo, naloxone, and oxycodone
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Naloxone
- Oxycodone
- Placebo
Oxycodone is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator