The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
1 other identifier
interventional
11
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 24, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 11, 2017
CompletedApril 11, 2017
January 1, 2017
10 months
February 24, 2012
January 6, 2017
February 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
PET/MRI Brain Activation
Simultaneously collect fMRI-PET data in humans to investigate the change between bold signal evoked by pressure pain and bold signal evoked by non-painful pressure. The PET analyses generates one value per 120 minutes. This value is compared to the other 120 minute scan PET value in order to reflect the change.
day one
Study Arms (1)
healthy controls
EXPERIMENTALInterventions
Up to a 120 minute PET scan using \[11C\]diprenorphine as the radiotracer
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Charlestown, Massachusetts, 02139, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jian Kong
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Kong, MD (equiv), MS, MPH
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 24, 2012
First Posted
March 7, 2012
Study Start
December 1, 2011
Primary Completion
October 1, 2012
Study Completion
December 1, 2015
Last Updated
April 11, 2017
Results First Posted
April 11, 2017
Record last verified: 2017-01