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NCT01222091 · ClinicalTrials.gov registry record · Phase 2
Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids
A Phase 2 study of Hyperalgesia, sponsored by Stanford University.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01222091: Completed Phase 2 study of Hyperalgesia, sponsored by Stanford University.
NCT01222091 is a Phase 2 study of Hyperalgesia that has completed, run by Stanford University. The registered enrollment target is 10 participants, below the 214-participant average among 4 other Hyperalgesia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01222091, a Phase 2 study of Hyperalgesia, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study explores whether a beta-blocker (propranolol) can prevent a person from becoming more sensitive to pain after administration of an opioid (remifentanil). Beta blockers inhibit the sympathetic (fight or flight) response and are often used to treat angina and high blood pressure. In a previous study in human volunteers, the investigators demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.
Primary Outcome
A slightly modified version of a previously described model of secondary hyperalgesia was used. Two copper wires contained in a microdialysis catheter were inserted in parallel over a length of 5 mm into the dermis of the right volar forearm. The wires were connected to a constant current stimulator controlled by a pulse generator to deliver rectangular and monophasic pulses with a duration of 0.5 mg at 2 Hz. Over a period of 15 min, the current was increased by targeting a pain rating of 5 on a
Conditions Studied
Interventions
- DRUG Propranolol
- DRUG Remifentanil
- DRUG Placebo to Match Propranolol
Study Locations (1)
California
- Stanford University School of Medicine - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01222091 record still lists
NCT01222091 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 214-participant average among 4 other Hyperalgesia trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Hyperalgesia appearing as the primary indexed condition, and to 3 interventions - of which Propranolol is the first listed.
NCT01222091 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01222091 about?
NCT01222091 is a clinical study titled "Study on the Effect of a Beta Blocker on Increased Sensitivity to Pain in Humans Caused by Opioids". This research study explores whether a beta-blocker (propranolol) can prevent a person from becoming more sensitive to pain after administration of an opioid (remifentanil). Beta blockers inhibit the sympathetic (fight or flight) response and are often used to treat angina and high blood pressure. I...
What is the current status of trial NCT01222091?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2009-02. Estimated completion is 2011-06.
What conditions does trial NCT01222091 study?
This clinical trial studies the following conditions: Hyperalgesia.
What interventions are being tested in trial NCT01222091?
The interventions under investigation include: Propranolol (DRUG), Remifentanil (DRUG), Placebo to Match Propranolol (DRUG).
Who is sponsoring clinical trial NCT01222091?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01222091 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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