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: October 29, 2013
Last verified: October 2013
  Purpose

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 Intervention
Healthy Controls
Radiation: PET imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • PET/MRI brain activation [ Time Frame: one day ] [ Designated as safety issue: No ]
    This is a pilot study to help inform future research.


Estimated Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: healthy controls Radiation: PET imaging
Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546155

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

No publications provided

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01546155     History of Changes
Other Study ID Numbers: 2011P0022171
Study First Received: February 24, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diprenorphine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014