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Brain Imaging and Pain: Analysis of Placebo Analgesia

Primary Purpose

Brain Imaging of Placebo Analgesia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo Instructions
Control condition
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Brain Imaging of Placebo Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • at least 18 years of age
  • english speaking

Exclusion Criteria:

  • pain condition
  • pregnant

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Control condition

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 2, 2011
Last Updated
March 19, 2015
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01409538
Brief Title
Brain Imaging and Pain: Analysis of Placebo Analgesia
Official Title
Brain Imaging and Pain: Analysis of Placebo Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study examines the brain activation associated with placebo pain reduction.
Detailed Description
This study is a basic science study of the mechanisms of placebo analgesia in asymptomatic healthy individuals. Each participant receives a baseline pain testing session, followed by a conditioning paradigm that results in expectation of pain relief and conditioning. They then undergo functional magnetic resonance imaging during either placebo (conditioned analgesia) or baseline. To examine order effects and habituation, the participants also either undergo a repeated placebo or a repeated baseline. The primary dependent measures in the study are the fMRI determined regions of interest, in a network of brain areas associated with pain processing. The anticipated outcome of the study is the alteration of network connectivity between sensory, affective, evaluative areas of the brain associated with placebo. Because this is not a traditional clinical trial, there are not traditional efficacy criteria, rather the outcomes are changes in brain function from manipulations of patient expectation and classical conditioning.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Imaging of Placebo Analgesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.
Intervention Type
Other
Intervention Name(s)
Placebo Instructions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control condition
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brain Imaging Results
Description
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.
Time Frame
2 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: at least 18 years of age english speaking Exclusion Criteria: pain condition pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Robinson, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25659463
Citation
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.
Results Reference
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PubMed Identifier
23548484
Citation
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.
Results Reference
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PubMed Identifier
24998897
Citation
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.
Results Reference
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PubMed Identifier
23743257
Citation
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.
Results Reference
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PubMed Identifier
22854011
Citation
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.
Results Reference
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PubMed Identifier
25267208
Citation
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.
Results Reference
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PubMed Identifier
24412799
Citation
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.
Results Reference
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Brain Imaging and Pain: Analysis of Placebo Analgesia

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