Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms

Vanderbilt University Medical Center

Status

Enrolling

Conditions

Back Pain

Opioid Use Disorder

Stress

Treatments

Drug: Oxycodone

Drug: Placebo

Drug: Naloxone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05142267

210399

R01DA050334 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The purpose of this project is to advance mechanistic knowledge of how stress impacts differential opioid analgesic responses that enhance risk for opioid use disorder (OUD), potentially informing development of data-driven precision pain medicine algorithms to mitigate opioid related risks.

The study aims to determine whether subjective and physiological stress-related measures are associated with analgesic and misuse-relevant subjective responses to placebo-controlled oxycodone administration. The study also aims to evaluate associations between stress-related measures and both endogenous opioid (EO) function and endocannabinoid (EC) levels and to test whether EO and EC mechanisms contribute to associations between stress-related measures and oxycodone responses

Using a mixed between/within-subject design, the study will obtain baseline assessment of stress related markers followed by 3 laboratory sessions with assessment of endocannabinoids, back pain assessment, and exposure to standardized evoked pain stimuli after administration of placebo, naloxone, and oxycodone.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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