NCT03781570

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
541

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

May 21, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

4.9 years

First QC Date

December 14, 2018

Results QC Date

April 9, 2024

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 during pain tasks at a single 4 hour experimental session (within one month of screening completion).

Study Arms (1)

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.

Behavioral: Placebo CreamBehavioral: Control Cream

Interventions

Placebo CreamBEHAVIORAL

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.

Single group
Control CreamBEHAVIORAL

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.

Single group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado, Boulder

Boulder, Colorado, 80309, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will collect saliva samples during the fMRI scan day and genotype using the same facility (same laboratory, personnel, platform, and protocols), following standard GWAS quality control procedures.

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Tor D Wager, PhD
Organization
Dartmouth College

Study Officials

  • Tor Wager, PHD

    University of Colorado, Boulder

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cognitive and Affective Neuroscience Laboratory; Professor, Department of Psychology and Neuroscience and the Institute for Cognitive Science

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 20, 2018

Study Start

November 7, 2018

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

June 4, 2025

Results First Posted

May 21, 2025

Record last verified: 2025-05

Locations