PainNCT01878019
Brain Response to Pain Control in People With Chronic Pain
An observational study of Pain, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
Background: Researchers want to look at how the brain responds to painful stimulations. They also want to see if these responses are different in people with and without chronic pain. To test the brain s response, they will use a chemical called naloxone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2013to 8 Sep 2016
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be greater than or equal to 18 years of age.
- Patient must be able to comprehend English.
- Patient must be able to provide written informed consent.
- Patient must have had chronic widespread pain for at least one year prior to participation with an average daily intensity at least 4 out of 10.
- Healthy control must be greater than or equal to 18 years of age
- Healthy control must be able to comprehend English.
- Healthy control must be able to provide written informed consent.
Who cannot join
- Patient is unable to comply with study procedures or follow-up visits
- Patient smokes more than 10 cigarettes of nicotine per week.
- Patient uses recreational drugs.
- Female patient consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male patient consumes 14 such drinks per week. Further, patient consumes more than 5 drinks at one time.
- Patient is pregnant or breastfeeding.
- Patient has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition.
Show all 24Show fewer
- Patient has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts.
- Patient has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have.
- Patient is uncomfortable in small closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine.
- Patient cannot lie comfortably flat on his/her back for up to 75 minutes in the MRI scanner.
- Patient has allergies to topical treatment.
- Patient has a chronic pain condition other than FM.
- Patient has taken within the last two weeks opioids. Other medications used to treat fibromyalgia at the standard doses in the community can be taken. We will not ask participants to stop any medication to participate in the study.
- Patient has previously taken opioids for more than one month on a continual basis, within the last 6 months.
- Patient had seen study information on clinicaltrials.gov prior to September 23, 2013.
- Patients who decline to be audio and/or videotaped will be excluded from the qualitative interview component of the study.
- Healthy control is unable to comply with study procedures or follow-up visits
- Healthy control smokes more than 10 cigarettes of nicotine per week.
- Healthy control uses recreational drugs.
- Female healthy control consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male healthy control consumes 14 such drinks per week. Further, healthy control consumes more than 5 drinks at one time.
- Healthy control is pregnant or breastfeeding.
- Healthy control has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition.
- Healthy control has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts.
- Healthy control has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments,
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Mechanisms of Pain Control in Chronic Pain Patients
Background:
- Researchers want to look at how the brain responds to painful stimulations. They also want to see if these responses are different in people with and without chronic pain. To test the brain s response, they will use a chemical called naloxone. Naloxone is used to treat overdoses of painkilling drugs like morphine. It may be able to block the effect of a pain-relieving cream. Researchers will apply a pain-relieving cream to a person s lower leg and look at the results of sensitivity tests with either naloxone or a placebo. This study will compare the results from people with chronic pain (like fibromyalgia) to those of people without chronic pain.
Read more
Objectives:
- To look at the brain s response to pain in people with and without chronic pain.
Eligibility:
- Individuals at least 18 years of age who have fibromyalgia.
- Healthy volunteers at least 18 years of age.
Design:
- This study will involve a screening visit and two testing visits. The testing visits will be about a week apart.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. After the screening participants will be administered several questionnaires about their personality, and their thoughts and feelings.
- At the first visit, participants will try out the magnetic resonance imaging (MRI) scan before using it at the next visit. They will then have the painkilling cream applied on one part of their lower leg and a normal moisturizing cream on the other part of their lower leg. They will have heat pulses on these skin areas and rate the pain.
- At the second visit, participants will have tests in the MRI scanner. The heat pulse tests will be repeated after an infusion of either naloxone or a placebo.
Read the detailed description
Different pain reducing drugs work in different ways to reduce pain. Many drugs, including morphine and codeine, reduce pain by binding to opiate receptors in the brain. Another chemical, naloxone, can block the effect of these drugs. In this study, we are looking at brain responses to a pain-relieving cream and whether naloxone blocks the effect of the cream. We will compare the results of people with chronic pain (fibromyalgia) to those of people without chronic pain.
Design:
The study compares MRI response to painful stimulation between people with fibromyalgia and healthy volunteers under two conditions: 1) naloxone, 2) placebo.
Outcome measures: Pain ratings and pain-related MRI responses are compared between people with fibromyalgia and healthy volunteers
- Conditions
- Pain
- Keywords
- Pain, Placebo, Opiate Antagonist
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Perception
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study start28 May 2013
- Primary completion8 Sep 2016
- Study completion8 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mary C Bushnell, Ph.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878019
- Sponsor's protocol ID
- 130143
- Other IDs
- 13-AT-0143
- Status last verified
- 8 Sep 2016
- First submitted
- 12 Jun 2013
- Last updated
- 9 Dec 2019
- Results posted
- No
Publications
Apkarian AV, Sosa Y, Sonty S, Levy RM, Harden RN, Parrish TB, Gitelman DR. Chronic back pain is associated with decreased prefrontal and thalamic gray matter density. J Neurosci. 2004 Nov 17;24(46):10410-5. doi: 10.1523/JNEUROSCI.2541-04.2004.
PubMed 15548656Atlas LY, Bolger N, Lindquist MA, Wager TD. Brain mediators of predictive cue effects on perceived pain. J Neurosci. 2010 Sep 29;30(39):12964-77. doi: 10.1523/JNEUROSCI.0057-10.2010.
PubMed 20881115Baliki MN, Geha PY, Fields HL, Apkarian AV. Predicting value of pain and analgesia: nucleus accumbens response to noxious stimuli changes in the presence of chronic pain. Neuron. 2010 Apr 15;66(1):149-60. doi: 10.1016/j.neuron.2010.03.002.
PubMed 20399736
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Pain Control in Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT01878019
- Acronym / sponsor ID
- 130143
- Conditions
- Pain
- Keywords
- Pain, Placebo, Opiate Antagonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 28 May 2013
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 14 Jun 2013 (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.
Background:
- Researchers want to look at how the brain responds to painful stimulations. They also want to see if these responses are different in people with and without chronic pain. To test the brain s response, they will use a chemical called naloxone. Naloxone is used to treat overdoses of painkilling drugs like morphine. It may be able to block the effect of a pain-relieving cream. Researchers will apply a pain-relieving cream to a person s lower leg and look at the results of sensitivity tests with either naloxone or a placebo. This study will compare the results from people with chronic pain (like fibromyalgia) to those of people without chronic pain.
Objectives:
- To look at the brain s response to pain in people with and without chronic pain.
Eligibility:
- Individuals at least 18 years of age who have fibromyalgia.
- Healthy volunteers at least 18 years of age.
Design:
- This study will involve a screening visit and two testing visits. The testing visits will be about a week apart.
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. After the screening participants will be administered several questionnaires about their personality, and their thoughts and feelings.
- At the first visit, participants will try out the magnetic resonance imaging (MRI) scan before using it at the next visit. They will then have the painkilling cream applied on one part of their lower leg and a normal moisturizing cream on the other part of their lower leg. They will have heat pulses on these skin areas and rate the pain.
- At the second visit, participants will have tests in the MRI scanner. The heat pulse tests will be repeated after an infusion of either naloxone or a placebo.
Detailed description
Different pain reducing drugs work in different ways to reduce pain. Many drugs, including morphine and codeine, reduce pain by binding to opiate receptors in the brain. Another chemical, naloxone, can block the effect of these drugs. In this study, we are looking at brain responses to a pain-relieving cream and whether naloxone blocks the effect of the cream. We will compare the results of people with chronic pain (fibromyalgia) to those of people without chronic pain.
Design:
The study compares MRI response to painful stimulation between people with fibromyalgia and healthy volunteers under two conditions: 1) naloxone, 2) placebo.
Outcome measures: Pain ratings and pain-related MRI responses are compared between people with fibromyalgia and healthy volunteers
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient must be greater than or equal to 18 years of age.
- Patient must be able to comprehend English.
- Patient must be able to provide written informed consent.
- Patient must have had chronic widespread pain for at least one year prior to participation with an average daily intensity at least 4 out of 10.
- Healthy control must be greater than or equal to 18 years of age
Key exclusion criteria (24 listed)
- Patient is unable to comply with study procedures or follow-up visits
- Patient smokes more than 10 cigarettes of nicotine per week.
- Patient uses recreational drugs.
- Female patient consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male patient consumes 14 such drinks per week. Further, patient consumes more than 5 drinks at one time.
- Patient is pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain Perception
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Background: PubMed 15548656Apkarian AV, Sosa Y, Sonty S, Levy RM, Harden RN, Parrish TB, Gitelman DR. Chronic back pain is associated with decreased prefrontal and thalamic gray matter density. J Neurosci. 2004 Nov 17;24(46):10410-5. doi: 10.1523/JNEUROSCI.2541-04.2004.
- Background: PubMed 20881115Atlas LY, Bolger N, Lindquist MA, Wager TD. Brain mediators of predictive cue effects on perceived pain. J Neurosci. 2010 Sep 29;30(39):12964-77. doi: 10.1523/JNEUROSCI.0057-10.2010.
- Background: PubMed 20399736Baliki MN, Geha PY, Fields HL, Apkarian AV. Predicting value of pain and analgesia: nucleus accumbens response to noxious stimuli changes in the presence of chronic pain. Neuron. 2010 Apr 15;66(1):149-60. doi: 10.1016/j.neuron.2010.03.002.
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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.
Mary C Bushnell, Ph.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by National Center for Complementary and Integrative Health (NCCIH) 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 24 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: finished, as of the sponsor's last update on 9 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Perception (time frame: 3 years). 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 NCT01878019, which also lists 3 linked publications.
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 9 Dec 2019.