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Brain Imaging and Pain: Analysis of Placebo Analgesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01409538
First received: August 2, 2011
Last updated: March 19, 2015
Last verified: March 2015
  Purpose
This study examines the brain activation associated with placebo pain reduction.

Condition Intervention Phase
Brain Imaging of Placebo Analgesia
Other: Placebo Instructions
Other: Control condition
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Brain Imaging and Pain: Analysis of Placebo Analgesia

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Brain Imaging Results [ Time Frame: 2 weeks from baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 140
Study Start Date: January 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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
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.
Active Comparator: Control condition
The control condition represents a no-intervention, repeated baseline control, since the "active" intervention in this study is placebo.
Other: Control condition
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • at least 18 years of age
  • english speaking

Exclusion Criteria:

  • pain condition
  • pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409538

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Michael E Robinson, Ph.D. University of Florida
  More Information

Publications:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01409538     History of Changes
Other Study ID Numbers: R01 AT001424-05A 
Study First Received: August 2, 2011
Last Updated: March 19, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on December 02, 2016