Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

Inflammation Clinical Trial

Official title:

Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01749826
• Other study ID #: SU-10212009-4201
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Est. completion date: July 2013

Study information

• Verified date: January 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation

Intervention

Drug:
• Morphine Sulfate
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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Cytokine Release	5 CCs of blood are drawn on day 1 and day 30.	Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
Secondary	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.	Changes in laser doppler images are measured between images taken on Day 1 and Day 30
Secondary	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.	Differences in heat pain are assessed between measurements taken on Day 1 and Day 30
Secondary	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	Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30