PainPhase 2NCT05669924
Neural Correlates of Acute Pain Dynamics
A Phase 2 study testing Methylphenidate in people with Pain, run by Northwestern University at 1 site in United States.
Trial summary
This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2022to 26 Apr 2024
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- Pregnant
- History of chronic pain
- History of neurological diagnosis
- History of psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics
This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.
- Conditions
- Pain
- Being tested
- Methylphenidate, Placebo
- Keywords
- Mesolimbic system, Dopamine circuits, Psychophysics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
0.35 mg/kg methylphenidate will be administered after baseline testing and 45 min-1 hr before post-intervention testing.
PlaceboDrug
Placebo for methylphenidate
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Not described Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of methylphenidate on acute pain dynamics
We will compare acute pain dynamics-i.e., the time series of pain visual analog scale ratings (0-100, where 0 = no pain and 100 = worst pain imaginable) obtained while delivering a changing noxious stimulus-during the methylphenidate condition to that of the placebo condition.
Measured: 6 months
Nucleus accumbens activation with acute pain dynamics
We will regress the time course of nucleus accumbens BOLD activity onto the latent time series obtained from our valence competition model. This will be supported by regressing the nucleus accumbens time course onto the pain VAS time course, allowing our findings to be compared to standard analyses in the literature.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start19 Sep 2022
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Vigotsky, Northwestern University
- Investigators
- Andrew D Vigotsky, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669924
- Sponsor's protocol ID
- STU00213557
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be anonymized and shared on OpenPain.org upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics
- ClinicalTrials.gov ID
- NCT05669924
- Acronym / sponsor ID
- STU00213557
- Conditions
- Pain
- Keywords
- Mesolimbic system, Dopamine circuits, Psychophysics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 3 Jan 2023 (actual)
- 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.
This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (4 listed)
- Pregnant
- History of chronic pain
- History of neurological diagnosis
- History of psychiatric diagnosis
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 |
|---|---|---|
| Methylphenidate0.35 mg/kg methylphenidate will be administered after baseline testing and 45 min-1 hr before post-intervention testing. | Drug | Methylphenidate |
| PlaceboPlacebo for methylphenidate | Drug | Placebo |
Primary outcome
Effect of methylphenidate on acute pain dynamics
Time frame: 6 months
We will compare acute pain dynamics-i.e., the time series of pain visual analog scale ratings (0-100, where 0 = no pain and 100 = worst pain imaginable) obtained while delivering a changing noxious stimulus-during the methylphenidate condition to that of the placebo condition.
Nucleus accumbens activation with acute pain dynamics
Time frame: 6 months
We will regress the time course of nucleus accumbens BOLD activity onto the latent time series obtained from our valence competition model. This will be supported by regressing the nucleus accumbens time course onto the pain VAS time course, allowing our findings to be compared to standard analyses in the literature.
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 1 May 2024.
- Individual participant dataSharing planned: Yes. Data will be anonymized and shared on OpenPain.org upon publication.
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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.
Andrew D Vigotsky, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylphenidate in people with Pain, run by Northwestern 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 1 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: finished, as of the sponsor's last update on 1 May 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Effect of methylphenidate on acute pain dynamics (time frame: 6 months). The study lists 2 primary outcomes in all. 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 1 May 2024.