Understanding how stress affects opioid pain medication misuse
Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms
This study is testing how stress affects the use of opioid pain medications in people with chronic back pain to see if it leads to misuse or impacts how well the medication works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05142267 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between stress and the risk of opioid misuse in patients with chronic back pain. It aims to explore how stress influences the effectiveness of opioid medications and the potential for misuse by examining both subjective and physiological stress responses. Participants will undergo assessments of stress markers and receive placebo, naloxone, or oxycodone in a controlled laboratory setting to evaluate their pain responses. The findings could lead to improved precision medicine approaches for managing pain and reducing opioid misuse risk.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with persistent daily low back pain lasting at least three months.
Not a fit: Patients with a history of substance abuse, certain psychiatric disorders, or chronic pain due to malignancy or autoimmune disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that help tailor pain management strategies to reduce the risk of opioid misuse in patients experiencing high levels of stress.
How similar studies have performed: Other studies have explored the relationship between stress and opioid responses, but this specific approach examining endogenous opioid and endocannabinoid mechanisms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Intact cognitive status and ability to provide informed consent * Ability to read and write in English sufficiently to understand and complete study questionnaires (which are only validated in English) * Age 18 or older And * Presence of persistent daily low back pain of at least three months duration and of at least a 3/10 in average intensity Exclusion Criteria: * History of renal or hepatic dysfunction * Reports of current or past alcohol or substance abuse or treatment for such condition * A reported history of PTSD, psychotic, or bipolar disorders * Chronic pain due to malignancy (e.g., cancer) or autoimmune disorders (e.g., rheumatoid arthritis, lupus) * Reports of recent benzodiazepine use (confirmed via rapid urine screening prior to each lab session) * Any medical conditions (e.g., significant cardiovascular disease) that the study physician feels would contraindicate participation in the lab stressors * 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) * Pregnancy (females only, to avoid fetal drug exposure - pregnancy tests conducted prior to each lab session to confirm eligibility) * Prior allergic reaction/intolerance to oxycodone or its analogs
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Bruehl, PhD — Vanderbilt University Medical Center
- Study coordinator: Stephen Bruehl, PhD
- Email: stephen.bruehl@vumc.org
- Phone: 615-936-1821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.