InflammationNCT01749826
Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
A study testing Morphine Sulfate in people with Inflammation, run by Stanford University at 1 site in United States.
Trial summary
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Morphine Sulfate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years old
- Healthy volunteer
- Not allergic to remifentanil
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
We aim to examine the extent to which inflammation is affected by acute and chronic opioid exposure.
Read the 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.
- Conditions
- Inflammation
- Being tested
- Morphine Sulfate
- Keywords
- Inflammation, opioids, immune system
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine SulfateDrug
Also called MS Contin, Morphine Sulfate ER, Roxanol, Kadian
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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Opioid Exposure | Experimental | 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. Receives: Drug: Morphine Sulfate |
| Acute Opioid Exposure | Experimental | 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. Receives: Drug: Morphine Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cytokine Release
5 CCs of blood are drawn on day 1 and day 30.
Measured: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30
Secondary outcomes (3)
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.
Measured: Changes in laser doppler images are measured between images taken on Day 1 and Day 30
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.
Measured: Differences in heat pain are assessed between measurements taken on Day 1 and Day 30
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
Measured: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: The cytokines in the samples were undetectable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Fu-nien Chu, Stanford University
- Investigators
- Dr Larry Fu-nien Chu, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749826
- Sponsor's protocol ID
- SU-10212009-4201
- Status last verified
- Jan 2019
- First submitted
- 9 Nov 2009
- Last updated
- 30 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Responses to Acute and Chronic Opioid Exposure in Humans
- ClinicalTrials.gov ID
- NCT01749826
- Acronym / sponsor ID
- SU-10212009-4201
- Conditions
- Inflammation
- Keywords
- Inflammation, opioids, immune system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The cytokines in the samples were undetectable.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Opioid Exposure | Experimental | Drug: Morphine Sulfate15mg 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. |
| Acute Opioid Exposure | Experimental | Drug: Morphine Sulfate15mg 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old
- Healthy volunteer
- Not allergic to remifentanil
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine SulfateAlso: MS Contin, Morphine Sulfate ER, Roxanol, Kadian15mg 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 | Acute Opioid Exposure, Chronic Opioid Exposure |
Primary outcome
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.
3 secondary outcomes
Laser Doppler Images
Time frame: 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
Mechanical Pain Stimuli
Time frame: Changes in mechanical pain stimuli will be assessed between measurements taken on Day 1 and Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Larry Fu-nien Chu principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine Sulfate in people with Inflammation, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cytokine Release (time frame: Changes in cytokine release are compared between blood samples drawn on Day 1 and Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.