INTERVENTIONALCOMPLETEDNCT05142267
Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-09-04
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE4
- Enrollment
- 101 (ACTUAL)
- Start date
- 2022-03-02
- Sponsor
- Vanderbilt University Medical Center
- Design
- NA · SINGLE GROUP · BASIC SCIENCE
- Locations
- 1
- Results record
- Not present in registry snapshot
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.
Opioid Use DisorderBack PainStress
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Research network
Researchers and organizations
Interventions
What was registered
DRUGPlacebo
In randomized order (crossover) across 3 laboratory sessions, participants will undergo laboratory evoked thermal pain response testing with: 1) 0.13 mg/kg of oral oxycodone (in 1mg/ml syrup) plus 20ml i.v. saline placebo, 2) 8mg of i.v. naloxone (in 20ml saline vehicle) plus oral placebo syrup (quantity matching oxycodone syrup volume), or 3) 20ml i.v. saline placebo plus oral placebo syrup (quantity matching oxycodone syrup volume). Thermal pain testing utilizes a Medoc TSAII NeuroSensory Analyzer. This equipment is used to assess heat pain threshold and tolerance using an ascending method of limits protocol.
normal saline placeboDRUGOxycodone
In randomized order (crossover) across 3 laboratory sessions, participants will undergo laboratory evoked thermal pain response testing with: 1) 0.13 mg/kg of oral oxycodone (in 1mg/ml syrup) plus 20ml i.v. saline placebo, 2) 8mg of i.v. naloxone (in 20ml saline vehicle) plus oral placebo syrup (quantity matching oxycodone syrup volume), or 3) 20ml i.v. saline placebo plus oral placebo syrup (quantity matching oxycodone syrup volume). Thermal pain testing utilizes a Medoc TSAII NeuroSensory Analyzer. This equipment is used to assess heat pain threshold and tolerance using an ascending method of limits protocol.
DRUGNaloxone
In randomized order (crossover) across 3 laboratory sessions, participants will undergo laboratory evoked thermal pain response testing with: 1) 0.13 mg/kg of oral oxycodone (in 1mg/ml syrup) plus 20ml i.v. saline placebo, 2) 8mg of i.v. naloxone (in 20ml saline vehicle) plus oral placebo syrup (quantity matching oxycodone syrup volume), or 3) 20ml i.v. saline placebo plus oral placebo syrup (quantity matching oxycodone syrup volume). Thermal pain testing utilizes a Medoc TSAII NeuroSensory Analyzer. This equipment is used to assess heat pain threshold and tolerance using an ascending method of limits protocol.
narcan Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Healthy volunteers
- Not accepted
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
primary outcomes
primary measures
Mean change in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to oxycodone condition
Time frame: Across 2 laboratory assessment days (an expected average of 15 day period)
Mean within participant changes in McGill Pain Questionnaire-2 (MPQ-2) ratings of low back pain from the placebo to oxycodone condition (across 2 testing days). The MPQ-2 score ranges from 0-10 where 0 represents no pain and 10 represents most intense pain. Positive change values indicate decreased pain responsiveness post intervention.
Mean DELTA Drug Liking subscale scores in the oxycodone condition
Time frame: One 1 laboratory assessment day
Mean DELTA Drug Liking subscale scores in the oxycodone condition. The DELTA Drug Liking subscale consists of a single item asking about overall perceived drug liking. The 1-5 scale is anchored with 1 representing dislike a lot and 5 representing like a lot.
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)
Time frame: Across 2 laboratory assessment days (an expected average of 15 day period)
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). More negative standardized values will indicate low levels of endogenous pain inhibition and more positive levels will indicate high levels of endogenous pain inhibition.
secondary outcomes
secondary measures
Mean changes in MPQ-2 ratings of ischemic task pain from the placebo to oxycodone condition
Time frame: Across 2 laboratory assessment days (an expected average of 15 day period)
Mean within participant changes in MPQ-2 ratings of ischemic task pain from the placebo to oxycodone condition. The MPQ-2 score ranges from 0-10 where 0 represents no pain and 10 represents most intense pain. Positive change values indicate decreased pain responsiveness.
Mean changes in Visual Analog Scale (VAS) intensity ratings of ischemic task pain from the placebo to oxycodone condition
Time frame: Across 2 laboratory assessment days (an expected average of 15 day period)
Mean within participant changes in VAS intensity ratings of ischemic task pain from the placebo to oxycodone condition. The score is a rating of current acute pain using a 0-100 visual analog scale (VAS) (0 = "no pain" and 100 = "worst possible pain")
Mean changes in MPQ-2 ratings of heat task pain from the placebo to oxycodone condition
Time frame: Across 2 laboratory assessment days (an expected average of 15 day period)
Mean within participant changes in MPQ-2 ratings of heat task pain from the placebo to oxycodone condition. The MPQ-2 score ranges from 0-10 where 0 represents no pain and 10 represents most intense pain. Positive change values indicate decreased pain responsiveness.
Mean changes in VAS intensity ratings of heat task pain from the placebo to oxycodone condition
Time frame: Across 2 laboratory assessment days (an expected average of 15 day period)
Mean within participant changes in VAS intensity ratings of heat task pain from the placebo to oxycodone condition. The score is a rating of current acute pain using a 0-100 visual analog scale (VAS) (0 = "no pain" and 100 = "worst possible pain")
DELTA Take Again subscale scores in the oxycodone condition
Time frame: 1 laboratory assessment day (an expected average of 15 day period)
Mean oxycodone condition Take Again (DELTA subscale) score. The score ranges from 1-5 where 1 represents definitely would not and 5 represents definitely would. Positive values indicate decreased overall drug effects post intervention.
Publications
Locally readable linked articles
background referenceMolecular Pain · Free full text Snapshot provenance
- Snapshot
- ef0d225c-71e6-4414-b831-992024d2a87c
- Retrieved
- 11/09/2026, 14:14:16
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