Pain, AcutePAINGENNCT03781570

Brain and Genetic Predictors of Individual Differences in Pain and Analgesia

An observational study of Pain, Acute, run by Trustees of Dartmouth College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to gain a better understanding of pain processing in the brain. Our understanding of how pain is processed in the brain is limited. We are testing for individual differences in pain perception and emotion. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Pain, Acute
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 541 participants
Where: 1 siteUnited States
Study dates: 7 Nov 2018to 1 Oct 2023
Phase: Observational
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 55 years
All sexes
Healthy volunteers accepted
Adult

Study population: The CTS includes 727 same-sex twin pairs between 26-38 years old (as of Spring 2017), originally derived from the Colorado Twin Registry, a population based registry, housed at the Institute for Behavioral Genetics (IBG) at the University of Colorado since 1984, with three previous waves of data collection (1997-2002, 2002-2008, and 2009-2014).

Who may be able to join

Participants must be registered in the Colorado Community Twin Sample (CTS).

Who cannot join

Not being registered in the Colorado Community Twin Sample (CTS).
Any MRI contraindications.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado, Boulder
Boulder, Colorado, 80309

Other trials in United States

About this study

Conditions: Pain, Acute
Being tested: Placebo Cream, Control Cream
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo CreamBehavioural
In the Placebo intervention, participants are given an inert cream with instructions that it is "Prodicaine, an effective pain-relieving drug". The cream is applied to two fingers on the left hand.
Control CreamBehavioural
In the Control intervention, participants are given an inert cream with instructions that it is "a control cream with no effects" . The cream is applied to two fingers on the left hand.

Study groups in NCT03781570
Study group	Role	What they receive
Single group		All participants are administered Control and Placebo creams (two interventions), with thermal and mechanical painful stimuli delivered repeatedly after each intervention. The order of intervention testing is Control, Placebo, Placebo, Control in a fixed order. All interventions are completed within a single testing session. Receives: Behavioral: Placebo Cream; Behavioral: Control Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Rating Scores Made on a Visual Analog Scale (VAS)
Self reported pain using a Visual Analogue Scale (VAS) ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)). Higher scores indicate more pain. 0 is the minimum value and 100 is the maximum value. This scale is used for both thermal and mechanical pain. Reported values reflect averages of VAS ratings for individual stimuli for each of thermal and mechanical pain.
Measured: Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 20181 Oct 2023

First posted20 Dec 2018
Study start7 Nov 2018
Primary completion1 Oct 2023
Study completion1 Oct 2023

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 Pain, AcuteStudies 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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 541 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03781570
Sponsor's protocol ID: Pain Genetics
Acronym: PAINGEN
Status last verified: May 2025
First submitted: 14 Dec 2018
Last updated: 4 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pain, Acute trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain and Genetic Predictors of Individual Differences in Pain and Analgesia
ClinicalTrials.gov ID: NCT03781570
Acronym / sponsor ID: PAINGEN / Pain Genetics
Conditions: Pain, Acute
Study type: Observational
Recruitment status: Completed
Enrolment: 541 participants (actual)
Lead sponsor: Trustees of Dartmouth CollegeUniversity, hospital or other
Collaborators: QIMR Berghofer Medical Research Institute
Study start: 7 Nov 2018 (actual)
Primary completion: 1 Oct 2023 (actual)
Study completion: 1 Oct 2023 (actual)
First posted: 20 Dec 2018 (actual)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Single group	–	Behavioral: Placebo Cream, Behavioral: Control CreamAll participants are administered Control and Placebo creams (two interventions), with thermal and mechanical painful stimuli delivered repeatedly after each intervention. The order of intervention testing is Control, Placebo, Placebo, Control in a fixed order. All interventions are completed within a single testing session.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: The CTS includes 727 same-sex twin pairs between 26-38 years old (as of Spring 2017), originally derived from the Colorado Twin Registry, a population based registry, housed at the Institute for Behavioral Genetics (IBG) at the University of Colorado since 1984, with three previous waves of data collection (1997-2002, 2002-2008, and 2009-2014).

Key inclusion criteria (1 listed)

Participants must be registered in the Colorado Community Twin Sample (CTS).

Key exclusion criteria (2 listed)

Not being registered in the Colorado Community Twin Sample (CTS).
Any MRI contraindications.

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
Placebo CreamIn the Placebo intervention, participants are given an inert cream with instructions that it is "Prodicaine, an effective pain-relieving drug". The cream is applied to two fingers on the left hand.	Behavioural	Single group
Control CreamIn the Control intervention, participants are given an inert cream with instructions that it is "a control cream with no effects" . The cream is applied to two fingers on the left hand.	Behavioural	Single group

Primary outcome

Pain Rating Scores Made on a Visual Analog Scale (VAS)
Time frame: Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).
Self reported pain using a Visual Analogue Scale (VAS) ranging from 0-100 (with 0 representing "no pain at all" and 100 representing "most intense pain imaginable (in the context of the experiment)). Higher scores indicate more pain. 0 is the minimum value and 100 is the maximum value. This scale is used for both thermal and mechanical pain. Reported values reflect averages of VAS ratings for individual stimuli for each of thermal and mechanical pain.

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Main	541	492

Primary outcome: Pain Rating Scores Made on a Visual Analog Scale (VAS)

Time frame: Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).. Mean (Standard Deviation). Unit: Score on a scale

Measure	Main n = 460
Placebo thermal pain ratings	0.136 (0.123)
Control thermal pain ratings	0.190 (0.141)
Placebo mechanical pain ratings	0.126 (0.174)
Control mechanical pain ratings	0.160 (0.178)

Main: Mean Difference (Final Values): -0.0544 (95% CI -0.0648 to -0.0441), p <0.001, Mixed Models Analysis

Population analysed: All participants completed both the placebo condition and the control condition. Participants completed both conditions and all analyses were completed within participants. Descriptions of arms and interventions are detailed in the Protocol Section.

Adverse events

Time frame: Adverse events were monitored for each participant during their participation (i.e., from the beginning to the end of their in person session). Participants were instructed to report any unusual events happening shortly after the experiment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Main	0 of 541 (0%)	0 of 541 (0%)	0 of 541

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Pain, Acute

Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)

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.

Tor Wager, PHD principal investigator

University of Colorado, Boulder

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, Acute, run by Trustees of Dartmouth College 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 2 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 4 Jun 2025. 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 21 May 2025). 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?

Pain Rating Scores Made on a Visual Analog Scale (VAS) (time frame: Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion).). 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 NCT03781570.

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 4 Jun 2025.