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.

Study Overview

• Status: Completed
• Conditions: Healthy Controls
• Intervention / Treatment: Radiation: PET imaging

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02139
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jian Kong, MD (equiv), MS, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: March 1, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: February 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2011P0022171