NCT02446262

Brief Summary

Background: \- Painful stimuli cause changes in a network of brain regions called the "Pain Matrix." But most of these regions respond to many other stimuli, not just pain. Researchers want to understand how different factors influence pain. They want to test what happens when people expect different levels of pain and receive treatments that can modify pain. They want to see if these factors influence decisions about pain and how the body responds to it. They also want to compare pain with responses like taste and vision. Objectives: \- To better understand how pain and emotions are processed and influenced by psychological factors. Eligibility: \- Healthy volunteers ages 18-50. Design:

  • This study requires 1 to 2 clinic visits that last 1 to 3 hours.
  • Participants will be screened with medical history and physical exam.
  • Some participants will have one or more magnetic resonance imaging (MRI) scans of their brain. For MRI, participants will lie on a table that slides in and out of a cylinder. The scanner makes loud knocking noises. They will get earplugs.
  • Participants heart activity will be recorded with electrocardiogram. Their pulse, sweating, and breathing will be monitored.
  • Some participants will take a taste test. Others may perform simple tasks. Others may receive pain in their arm, leg, or hand. The pain will come from heat or electric shocks. Others may judge pain using a topical pain-relieving cream. Some of these tests may be given during MRI.
  • Participants will fill out questionnaires.
  • The study will last 3 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for not_applicable pain

Timeline
9mo left

Started Jun 2015

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress93%
Jun 2015Feb 2027

First Submitted

Initial submission to the registry

May 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

June 11, 2015

Completed
11.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2027

Last Updated

March 9, 2026

Status Verified

January 5, 2026

Enrollment Period

11.7 years

First QC Date

May 14, 2015

Last Update Submit

March 6, 2026

Conditions

Keywords

PainVisual Analogue Pain ScalePlaceboAffective NeuroscienceFunctional Magnetic Resonance Imaging (fMRI)

Outcome Measures

Primary Outcomes (3)

  • Physiological responses (heart rate, skin conductance, respiration, pupil dilation, eye gaze position)

    In behavioral and fMRI experiments, we measure autonomic responses in anticipation and response to painful and non-painful stimuli using non-invasive measures.

    During the study visit in response to painful and non-painful stimuli.

  • Pain perception (pain ratings)

    Substudies of pain collect pain ratings using a visual analogue scale, either verbally or via computer.

    During the study visit in response to painful stimuli.

  • BOLD response in brain regions of interest measured using fMRI

    FMRI substudies proceed following behavioral substudies. We measure brain responses in anticipation and response to painful and non-painful stimuli.

    During the study visit in response to painful and non-painful stimuli.

Secondary Outcomes (1)

  • Questionnaire measures (e.g. State-trait anxiety index, Fear of Pain questionnaire, Intolerance of Uncertainty questionnaire, McGill Pain Questionnaire)

    Trait measures are collected during initial screening visit ; State measures are collected on every visit

Study Arms (8)

Substudy 1: Instructed subjects

OTHER

Participants are instructed about outcomes

Behavioral: Instructions

Substudy 1: Uninstructed subjects

OTHER

Participants learn through experience

Behavioral: Instructions

Substudy 2: heat group

OTHER

Participants learn about heat outcomes through conditioning

Behavioral: Thermal Pain

Substudy 2: salt group

OTHER

Participants learn about salt outcomes through conditioning

Behavioral: Thermal Pain

Substudy 2: sugar group

OTHER

Participants learn about sugar outcomes through conditioning

Behavioral: Thermal Pain

Substudy 3: healthy volunteers

NO INTERVENTION

All participants experience all outcomes, within subjects designs

Substudy 4: healthy volunteers

OTHER

Participants are instructed to attend toward or away from the stimulus

Behavioral: Attention

Substudy 5: healthy volunteers

OTHER

Participants experience both placebo and cue-based expectations within subjects

Behavioral: Placebo instructions

Interventions

InstructionsBEHAVIORAL

In sub-study 1, half the participants are instructed about outcomes, half learn through experience.

Substudy 1: Instructed subjectsSubstudy 1: Uninstructed subjects
AttentionBEHAVIORAL

In sub-study 4, participants learn about outcomes and we manipulate attention toward or away from the pain.

Substudy 4: healthy volunteers
Thermal PainBEHAVIORAL

In sub-studies 2 and 3, participants are exposed to thermal stimuli and/or tastants (sugar water, salt water, neutral rinse) and we are measuring how learning varies based on the type of outcome.

Substudy 2: heat groupSubstudy 2: salt groupSubstudy 2: sugar group

In sub-study 5, we test whether placebo effects and expectancy cues modulate pain through similar mechanisms.

Substudy 5: healthy volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Between 18 and 50 years old
  • Fluent in English
  • Able to provide written informed consent.

You may not qualify if:

  • Unable to comply with study procedures or follow-up visits.
  • Has a major medical condition or medical history that in a clinician's assessment could affect heat sensitivity, pain thresholds, or ability to comply with study procedures. This may include cardiovascular, autonomic, or neurological conditions, including stroke, blindness, deafness, a history of brain damage, or a chronic systemic disease (e.g., diabetes).
  • Has a current mood disorder, anxiety disorder, or substance use disorder, or has a history of psychosis, hospitalization for a mental health condition, or recurrent psychiatric episodes.
  • Has a medical condition that in a clinician's assessment might affect somatosensation (e.g., Raynaud s disease, peripheral neuropathy, or circulatory disorder).
  • Has a current chronic pain condition or has had chronic pain in the past (painful condition lasting more than six months).
  • Has a dermatological condition affecting the testing region such as scars, burns, or recent tattoos that might influence cutaneous sensibility.
  • Regular use of prescription medication that has a significant effect on pain or heat perception. Excluded medications include central-acting agents such as opiates (morphine, tramadol), antidepressants (amitriptyline, duloxetine, milnacipran), anticonvulsants (gabapentin, pregabalin), anxiolytics (barbituates, benzodiazepines), hypnotics (zolpidem, sodium oxybate), antipsychotics (valproate, lithium, olanzapine), antimigraine agents (sumatriptan, ergotamine), and muscle relaxants (cyclobenzaprine, carisoprodol). Use of analgesic medications, such as non-steroidal anti-inflammatories, salicylates, and acetaminophen, taken on an "as needed" basis is acceptable as long as the last dose taken was within 5 half-lives of testing.
  • Is pregnant.
  • NIH staff member who is a subordinate/relative/co-worker of any investigator on the protocol.
  • Individuals with conditions that could pose a risk relating to the safety of the fMRI procedure or pain stimulation will be excluded from the MRI portion of the protocol, but may participate in the non-fMRI sessions (with the exception of pregnant women). Such conditions include:
  • Those with ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip, implanted neural stimulator, cochlear implant, ocular foreign body.
  • Those with an abnormality on a structural MRI.
  • Those with an implanted cardiac pacemaker or auto-defibrillator.
  • Those with an insulin pump.
  • Those with irremovable body piercing.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (2)

  • Necka EA, Akintola T, Yu Q, Amir CM, Oretsky O, Atlas LY. Isolating Brain Mechanisms of Expectancy Effects on Pain: Cue-Based Stimulus Expectancies versus Placebo-Based Treatment Expectancies. J Neurosci. 2025 Aug 20;45(34):e0050252025. doi: 10.1523/JNEUROSCI.0050-25.2025.

  • Atlas LY, Dildine TC, Palacios-Barrios EE, Yu Q, Reynolds RC, Banker LA, Grant SS, Pine DS. Instructions and experiential learning have similar impacts on pain and pain-related brain responses but produce dissociations in value-based reversal learning. Elife. 2022 Nov 1;11:e73353. doi: 10.7554/eLife.73353.

Related Links

MeSH Terms

Conditions

Pain

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Lauren Y Atlas, Ph.D.

    National Center for Complementary and Integrative Health (NCCIH)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adebisi O Ayodele, C.R.N.P.

CONTACT

Lauren Y Atlas, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 18, 2015

Study Start

June 11, 2015

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Last Updated

March 9, 2026

Record last verified: 2026-01-05

Data Sharing

IPD Sharing
Will not share

We will share deidentified data only as per language in the protocol.

Locations