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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01546155
First received: February 24, 2012
Last updated: February 27, 2017
Last verified: January 2017
  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: No masking
Primary Purpose: Other
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: 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.



Enrollment: 11
Study Start Date: December 2011
Study Completion Date: December 2015
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   (Adult)
Sexes Eligible for Study:   All
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
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: 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

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
Results First Received: January 6, 2017
Last Updated: February 27, 2017

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

ClinicalTrials.gov processed this record on April 25, 2017