Pro-inflammatory ActivityPhase 1NCT01210066
Pain, Opioids and Pro-Inflammatory Immune Responses
A Phase 1 study testing Fentanyl, Cold pressor test and Fentanyl plus cold pressor test in people with Pro-inflammatory Activity and Immunologic Activity Alteration, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Providing pain management to the patient who abuses prescription opioids presents a clinical challenge, not only due to concerns about "drug-seeking", but because they have increased sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pro-inflammatory Activity, Immunologic Activity Alteration
- What is being tested?
- Fentanyl, Cold pressor test and Fentanyl plus cold pressor test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- male and non-pregnant female, non-smoking adults in good general health
- between the ages of 21-40 years old
- fluent in English with willingness to participate in the research study
- Supplementary Inclusion Criteria: Prescription Opioid Abusers
- DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
- compliance in treatment and on a stable dose of buprenorphine (6-24mg/day) x at least 10 days prior to screening
- Participation in an ISAP treatment program or a qualified community-based opioid treatment program or private clinic for the entire duration of their study participation
Who cannot join
- regular use of any medication that influences immune status or immune system function
- regular use of a medication that influences pain perception, including opioids (* only for healthy subjects population*)
- Regular use of a medication that influences pain perception, except for buprenorphine ( only for POA population)
- known hypersensitivity to opioids or no previous opioid exposure (*only healthy controls)
- presence of acute or chronic pain syndrome
- neuropsychiatric illness (i.e., peripheral neuropathy, schizophrenia) known to affect pain perception
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- presence of chronic immune compromise (hepatitis C, HIV) or acute infection within the last four weeks
- current or past history of high blood pressure, heart disease, or stroke, or currently have a pacemaker.
- current DSM-IV diagnosis
- BMI less than 18.5 or greater than 29.9
- History of sleep apnea
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA School of Nursing
Los Angeles, California, 90095
About this study
Providing pain management to the patient who abuses prescription opioids presents a clinical challenge, not only due to concerns about "drug-seeking", but because they have increased sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to examine the role of opioid-induced proinflammatory changes in these responses.
Read the detailed description
Both acute pain and opioid administration have been shown to induce a systemic pro-inflammatory response. However, the presence of these inflammatory responses is unknown in situations where a co-occurrence of pain and opioid administration exists as is the common clinical case of a patient with acute pain and taking opioid analgesics. A patient population for whom the combined effects of pain and opioids on immune function are particularly complex are the estimated 5.2 million Americans aged 12 or older who abuse prescription opioids. Not only are these individuals at risk for poor pain management due to their status as an "addict", but there is good preclinical evidence to suggest that their chronic opioid use brings with it a general state of systemic inflammation, and thus setting the patient up for a unique or enhanced inflammatory response to the combination of acute opioids and pain. To better understand the health implications of treating acute pain with opioids in patients and in particular, those who abuse prescription opioids, inflammatory responses to the main and interaction effects of acute pain and opioid administration will be examined in well-characterized samples of each. Specifically, we will evaluate the inflammatory and cytokine responses to: (1) experimental pain; (2) an acute opioid challenge; and (3) the combination of opioid administration followed by cold-pressor pain, in healthy control subjects and age- and gender-matched prescription opioid abusers.
- Being tested
- Fentanyl, Cold pressor test, Fentanyl plus cold pressor test
- Keywords
- inflammation, opioid-induced hyperalgesia, bupenorphine, prescription opioid abuse
- Medical subject headings
- Inflammation, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called opioid
IV fentanyl 1mcg/kg
Cold pressor testOther
Also called cold pressor task
Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes
Fentanyl plus cold pressor testOther
Also called opioid and cold pressor
fentanyl IV 1mcg/kg fifteen minutes prior to cold pressor test (arm submerged in ice water until no longer tolerable but no longer than 5 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Pain Challenge | Active comparator | Cold pressor test Receives: Other: Cold pressor test |
| Pain + Opioid Challenge | Active comparator | IV fentanyl 1mcg/kg followed by cold pressor test Receives: Other: Fentanyl plus cold pressor test |
| Opioid Challenge | Active comparator | Administration of fentanyl 1mcg/kg of subject weight Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma levels of pro-inflammatory cytokine IL-6
inflammatory cytokine activity will be evaluated with an in vivo approach over a three hour period of time to enable observation of the duration of opioid activity
Measured: 15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Unable to recruit prescription opioid abusers; ultimately no potential POA recruit passed the pre-screening process
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pro-inflammatory ActivityStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy A Compton, RN PhD FAAN, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210066
- Sponsor's protocol ID
- 5R21DA027558
- Status last verified
- Dec 2016
- First submitted
- 27 Sep 2010
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Compton P, Griffis C, Breen EC, Torrington M, Sadakane R, Tefera E, Irwin MR. Opioid treatment of experimental pain activates nuclear factor-kappaB. J Opioid Manag. 2015 Mar-Apr;11(2):115-25. doi: 10.5055/jom.2015.0261.
PubMed 25901477
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain, Opioids and Pro-Inflammatory Immune Responses
- ClinicalTrials.gov ID
- NCT01210066
- Acronym / sponsor ID
- 5R21DA027558
- Keywords
- inflammation, opioid-induced hyperalgesia, bupenorphine, prescription opioid abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit prescription opioid abusers; ultimately no potential POA recruit passed the pre-screening process
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Providing pain management to the patient who abuses prescription opioids presents a clinical challenge, not only due to concerns about "drug-seeking", but because they have increased sensitivity to pain, a phenomenon identified as opioid-induced hyperalgesia (OIH). In an effort to improve pain treatment, the aims of the proposed work are to evaluate the analgesic and hyperalgesic effects of opioids to acute pain in this vulnerable population, and to examine the role of opioid-induced proinflammatory changes in these responses.
Detailed description
Both acute pain and opioid administration have been shown to induce a systemic pro-inflammatory response. However, the presence of these inflammatory responses is unknown in situations where a co-occurrence of pain and opioid administration exists as is the common clinical case of a patient with acute pain and taking opioid analgesics. A patient population for whom the combined effects of pain and opioids on immune function are particularly complex are the estimated 5.2 million Americans aged 12 or older who abuse prescription opioids. Not only are these individuals at risk for poor pain management due to their status as an "addict", but there is good preclinical evidence to suggest that their chronic opioid use brings with it a general state of systemic inflammation, and thus setting the patient up for a unique or enhanced inflammatory response to the combination of acute opioids and pain. To better understand the health implications of treating acute pain with opioids in patients and in particular, those who abuse prescription opioids, inflammatory responses to the main and interaction effects of acute pain and opioid administration will be examined in well-characterized samples of each. Specifically, we will evaluate the inflammatory and cytokine responses to: (1) experimental pain; (2) an acute opioid challenge; and (3) the combination of opioid administration followed by cold-pressor pain, in healthy control subjects and age- and gender-matched prescription opioid abusers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Challenge | Active comparator | Other: Cold pressor testCold pressor test |
| Pain + Opioid Challenge | Active comparator | Other: Fentanyl plus cold pressor testIV fentanyl 1mcg/kg followed by cold pressor test |
| Opioid Challenge | Active comparator | Drug: FentanylAdministration of fentanyl 1mcg/kg of subject weight |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- male and non-pregnant female, non-smoking adults in good general health
- between the ages of 21-40 years old
- fluent in English with willingness to participate in the research study
- Supplementary Inclusion Criteria: Prescription Opioid Abusers
- DSM-IVR diagnosis of prescription opioid abuse or dependence disorder
Key exclusion criteria (11 listed)
- regular use of any medication that influences immune status or immune system function
- regular use of a medication that influences pain perception, including opioids (* only for healthy subjects population*)
- Regular use of a medication that influences pain perception, except for buprenorphine ( only for POA population)
- known hypersensitivity to opioids or no previous opioid exposure (*only healthy controls)
- presence of acute or chronic pain syndrome
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 |
|---|---|---|
| FentanylAlso: opioidIV fentanyl 1mcg/kg | Drug | Opioid Challenge |
| Cold pressor testAlso: cold pressor taskNon-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes | Other | Pain Challenge |
| Fentanyl plus cold pressor testAlso: opioid and cold pressorfentanyl IV 1mcg/kg fifteen minutes prior to cold pressor test (arm submerged in ice water until no longer tolerable but no longer than 5 minutes) | Other | Pain + Opioid Challenge |
Primary outcome
plasma levels of pro-inflammatory cytokine IL-6
Time frame: 15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,
inflammatory cytokine activity will be evaluated with an in vivo approach over a three hour period of time to enable observation of the duration of opioid activity
Results and safety
The study was stopped early (reason given: Unable to recruit prescription opioid abusers; ultimately no potential POA recruit passed the pre-screening process). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Results publication: PubMed 25901477Compton P, Griffis C, Breen EC, Torrington M, Sadakane R, Tefera E, Irwin MR. Opioid treatment of experimental pain activates nuclear factor-kappaB. J Opioid Manag. 2015 Mar-Apr;11(2):115-25. doi: 10.5055/jom.2015.0261.
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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.
Peggy A Compton, RN PhD FAAN principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fentanyl, Cold pressor test and Fentanyl plus cold pressor test in people with Pro-inflammatory Activity and Immunologic Activity Alteration, run by University of California, Los Angeles 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 7 inclusion and 11 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 29 Dec 2016. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit prescription opioid abusers; ultimately no potential POA recruit passed the pre-screening process). Results are not available in the source record.
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?
plasma levels of pro-inflammatory cytokine IL-6 (time frame: 15 minutes prior to fentanyl administration, 60 and 180 minutes post fentanyl administration,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01210066, which also lists 1 linked publication.
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 29 Dec 2016.