Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans

January 6, 2019 updated by: Larry Fu-nien Chu, Stanford University
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Chronic Opioid Exposure
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.
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.
Other Names:
  • Kadian
  • MS Contin
  • Morphine Sulfate ER
  • Roxanol
Experimental: Acute Opioid Exposure
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.
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.
Other Names:
  • Kadian
  • MS Contin
  • Morphine Sulfate ER
  • Roxanol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Cytokine Release
Time Frame: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Laser Doppler Images
Time Frame: Changes in laser doppler images are measured between images taken on Day 1 and Day 30
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
Peltier Device-Heat Pain
Time Frame: Differences in heat pain are assessed between measurements taken on Day 1 and Day 30
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
Mechanical Pain Stimuli
Time Frame: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SU-10212009-4201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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