NCT01409538

Brief Summary

This study examines the brain activation associated with placebo pain reduction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

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

January 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

5 years

First QC Date

August 2, 2011

Last Update Submit

March 19, 2015

Conditions

Brain Imaging of Placebo Analgesia

Outcome Measures

Primary Outcomes (1)

  • Brain Imaging Results

    This outcomes represents the neural network underpinnings of the placebo analgesic response. It is the result of a network analysis using structural equation modeling of fMRI determined brain activations.

    2 weeks from baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Asymptomatic control participants receive Natural History and Placebo instructions in a within-subject design. There are no patients, or active agents in this study. It is not a Clinical Trial.

Other: Placebo Instructions

Control condition

ACTIVE COMPARATOR

The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.

Other: Control condition

Interventions

Placebo InstructionsOTHER

There is no intervention in this study. It is not a Clinical Trial. The study is an investigation of the neural basis of placebo analgesia.

Placebo
Control conditionOTHER

This protocol represents an investigation of the neural mechanisms of placebo analgesia. As such, it does not represent the traditional clinical trial design. Instead the "active" intervention is a placebo, and the comparison condition is a no-intervention control.

Control condition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • english speaking

You may not qualify if:

  • pain condition
  • pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (7)

  • Sevel LS, O'Shea AM, Letzen JE, Craggs JG, Price DD, Robinson ME. Effective connectivity predicts future placebo analgesic response: A dynamic causal modeling study of pain processing in healthy controls. Neuroimage. 2015 Apr 15;110:87-94. doi: 10.1016/j.neuroimage.2015.01.056. Epub 2015 Feb 3.

    PMID: 25659463BACKGROUND

  • Robinson ME, Staud R, Price DD. Pain measurement and brain activity: will neuroimages replace pain ratings? J Pain. 2013 Apr;14(4):323-7. doi: 10.1016/j.jpain.2012.05.007.

    PMID: 23548484BACKGROUND

  • Letzen JE, Sevel LS, Gay CW, O'Shea AM, Craggs JG, Price DD, Robinson ME. Test-retest reliability of pain-related brain activity in healthy controls undergoing experimental thermal pain. J Pain. 2014 Oct;15(10):1008-14. doi: 10.1016/j.jpain.2014.06.011. Epub 2014 Jul 3.

    PMID: 24998897BACKGROUND

  • Letzen JE, Craggs JG, Perlstein WM, Price DD, Robinson ME. Functional connectivity of the default mode network and its association with pain networks in irritable bowel patients assessed via lidocaine treatment. J Pain. 2013 Oct;14(10):1077-87. doi: 10.1016/j.jpain.2013.04.003. Epub 2013 Jun 3.

    PMID: 23743257BACKGROUND

  • Kisaalita NR, Robinson ME. Analgesic placebo treatment perceptions: acceptability, efficacy, and knowledge. J Pain. 2012 Sep;13(9):891-900. doi: 10.1016/j.jpain.2012.06.003. Epub 2012 Jul 31.

    PMID: 22854011BACKGROUND

  • Kisaalita N, Staud R, Hurley R, Robinson M. Placebo use in pain management: The role of medical context, treatment efficacy, and deception in determining placebo acceptability. Pain. 2014 Dec;155(12):2638-2645. doi: 10.1016/j.pain.2014.09.029. Epub 2014 Sep 28.

    PMID: 25267208BACKGROUND

  • Craggs JG, Price DD, Robinson ME. Enhancing the placebo response: functional magnetic resonance imaging evidence of memory and semantic processing in placebo analgesia. J Pain. 2014 Apr;15(4):435-46. doi: 10.1016/j.jpain.2013.12.009. Epub 2014 Jan 9.

    PMID: 24412799BACKGROUND

Study Officials

  • Michael E Robinson, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2011

First Posted

August 4, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

US(1)