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NCT02469077 · ClinicalTrials.gov registry record · NA
Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
NCT02469077: Completed NA study, sponsored by Vanderbilt University Medical Center.
NCT02469077 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 117 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02469077, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
Study Summary
Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (via greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deaths. Treatment strategies that minimize the need for chronic high-dose opioids are sorely needed. This project will test the novel hypothesis that effective pain relief can be achieved at lower opioid analgesic doses by increasing levels of endogenous opioids (EOs).
Primary Outcome
At a laboratory testing day pre and post intervention each participant received morphine sulphate (0.3mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02 mg/kg each with testing for thermal evoked pain response. Weight adjusted dosing was used by multiplying the weight of each patient in kg by 0.3mg (dose 1 only) or by .02mg (doses 2-4), with all doses infused in 20mL saline vehicle. Mean of the change in morphine dosage required to achieve 25 % reduction in thermal
Interventions
- DRUG Placebo
- DRUG Morphine
- DRUG naloxone
- BEHAVIORAL 6 week aerobic exercise intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2015-08 |
| Est. Completion | 2019-09 |
| Phase | NA |
What the finished NCT02469077 record still lists
NCT02469077 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02469077 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02469077 about?
NCT02469077 is a clinical study titled "Reduced Opioid Analgesic Requirements Via Improved Endogenous Opioid Function". Chronic Pain (CP) management has increasingly utilized long-term opioid analgesic therapy, a change associated with increased opioid abuse (via greater exposure in vulnerable individuals), non-pain health consequences (hormone changes, falls), and a dramatic rise in opioid-related overdoses and deat...
What is the current status of trial NCT02469077?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2015-08. Estimated completion is 2019-09.
What interventions are being tested in trial NCT02469077?
The interventions under investigation include: Placebo (DRUG), Morphine (DRUG), naloxone (DRUG), 6 week aerobic exercise intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02469077?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02469077's enrollment target sits among peer trials
117 807th of 2000 higher than 1,193 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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