search
Back to results

Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

Primary Purpose

Inflammation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morphine Sulfate
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inflammation focused on measuring Inflammation, opioids, immune system

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-60 years old
  • Healthy volunteer
  • Not allergic to remifentanil

Exclusion Criteria:

  • Patients younger than 18 or older than 70
  • Patients unwilling or unable to follow study instructions
  • Patients who don't speak English
  • Patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as Advil or Naproxen during 2 weeks prior to and during the 1 month study

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chronic Opioid Exposure

Acute Opioid Exposure

Arm Description

15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.

15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.

Outcomes

Primary Outcome Measures

Changes in Cytokine Release
5 CCs of blood are drawn on day 1 and day 30.

Secondary Outcome Measures

Laser Doppler Images
The laser doppler is a noninvasive, painless measurement of superficial perfusion that reflects inflammation. Laser doppler images will be taken once per study visit.
Peltier Device-Heat Pain
A hand-held 0.6x0.6 inch metal probe will be brought into contact with the patient's skin. Starting at 95 F, the probe temperature will increase at a rate of 1.8 F per second. The patient will be asked to push a button of a hand-held device as soon as the patient feels pain.
Mechanical Pain Stimuli
Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain: Stroking stimulus: skin will be tested with a brush that is moved three times across the lesion Punctuated stimulus: a metal rod (1/100 of an inch in diameter) mounted onto 10 different weights (0.03-2.9 ounces) will repetitively be placed onto the skin Blunt stimulus: a flat probe (0.4 inch in diameter) will be placed five times onto the patient's skin

Full Information

First Posted
November 9, 2009
Last Updated
January 6, 2019
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT01749826
Brief Title
Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
Official Title
Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
The cytokines in the samples were undetectable.
Study Start Date
January 2010 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.
Detailed Description
We are interested in learning how the immune system and the inflammation process is effected by acute and chronic opioid exposure. Preliminary evidence in animal models show that acute opioid exposure leads to decreased inflammatory responses, while chronic opioid exposure causes increased inflammatory responses, as measured by local cytokine release at the site of injury. Translating these findings to humans will lead to important new mechanistic knowledge that may ultimately improve our ability to treat pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Inflammation, opioids, immune system

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Opioid Exposure
Arm Type
Experimental
Arm Description
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
Arm Title
Acute Opioid Exposure
Arm Type
Experimental
Arm Description
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
MS Contin, Morphine Sulfate ER, Roxanol, Kadian
Intervention Description
15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
Primary Outcome Measure Information:
Title
Changes in Cytokine Release
Description
5 CCs of blood are drawn on day 1 and day 30.
Time Frame
Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
Secondary Outcome Measure Information:
Title
Laser Doppler Images
Description
The laser doppler is a noninvasive, painless measurement of superficial perfusion that reflects inflammation. Laser doppler images will be taken once per study visit.
Time Frame
Changes in laser doppler images are measured between images taken on Day 1 and Day 30
Title
Peltier Device-Heat Pain
Description
A hand-held 0.6x0.6 inch metal probe will be brought into contact with the patient's skin. Starting at 95 F, the probe temperature will increase at a rate of 1.8 F per second. The patient will be asked to push a button of a hand-held device as soon as the patient feels pain.
Time Frame
Differences in heat pain are assessed between measurements taken on Day 1 and Day 30
Title
Mechanical Pain Stimuli
Description
Pain sensitivity will be tested with three different mechanical stimuli that can elicit mild pain: Stroking stimulus: skin will be tested with a brush that is moved three times across the lesion Punctuated stimulus: a metal rod (1/100 of an inch in diameter) mounted onto 10 different weights (0.03-2.9 ounces) will repetitively be placed onto the skin Blunt stimulus: a flat probe (0.4 inch in diameter) will be placed five times onto the patient's skin
Time Frame
Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-60 years old Healthy volunteer Not allergic to remifentanil Exclusion Criteria: Patients younger than 18 or older than 70 Patients unwilling or unable to follow study instructions Patients who don't speak English Patients who are taking prescription opioid medications (e.g. vicodin, percocet) or are unwilling to refrain from taking anti-inflammatory medications such as Advil or Naproxen during 2 weeks prior to and during the 1 month study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Larry Fu-nien Chu
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

We'll reach out to this number within 24 hrs