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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546155
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Controls Radiation: PET imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
Study Start Date : December 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: healthy controls Radiation: PET imaging
Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer

Primary Outcome Measures :
  1. PET/MRI Brain Activation [ Time Frame: day one ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546155

United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02139
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Jian Kong, MD (equiv), MS, MPH Massachusetts General Hospital

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital Identifier: NCT01546155     History of Changes
Other Study ID Numbers: 2011P0022171
First Posted: March 7, 2012    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents