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The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01546155
First received: February 24, 2012
Last updated: November 14, 2012
Last verified: November 2012
History of Changes

February 24, 2012
November 14, 2012
December 2011
October 2012   (final data collection date for primary outcome measure)
PET/MRI brain activation [ Time Frame: one day ] [ Designated as safety issue: No ]
This is a pilot study to help inform future research.
Same as current
Complete list of historical versions of study NCT01546155 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials

Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of ([11C]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Controls
Radiation: PET imaging
Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male and female adults, 21 to 50 years of age
  • No contraindications to fMRI and PET scanning
  • Within 15% of ideal body mass index (BMI)

Exclusion Criteria:

  • Current significant medical, neurological, or psychiatric illness as assessed by the Physician Investigators
  • Women who are pregnant or breast feeding, have gone through menopause, and/or have irregular menstrual cycles
  • Claustrophobia
  • History of head trauma
  • Instability of responses to experimental pain (See Study Procedure Section Part II)
  • History of asthma
  • Use of psychotropic drugs or hormone treatments (including hormonal birth control) within one year of date of consent
  • History of smoking
  • Routine exercise in excess of one hour per day and/or three times per week
  • Non-fluent English speaker
Both
21 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01546155
2011P0022171
No
Jian Kong, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Jian Kong, MD (equiv), MS, MPH Massachusetts General Hospital
Massachusetts General Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP