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

Healthy Controls Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01546155
• Other study ID #: 2011P0022171
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2012
• Last updated: April 6, 2015
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Controls

Intervention

Radiation:
• PET imaging
Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET/MRI brain activation	This is a pilot study to help inform future research.	one day	No