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

Not Applicable

Completed

• Conditions: Healthy Controls
• Interventions: Radiation: PET imaging

• Registration Number: NCT01546155
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-24
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-07
• Primary Completion: 2012-10
• Study Completion: 2015-12
• Status Verified: 2017-01
• Results First Submitted: 2017-01-06
• Results First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Results First Posted: 2017-04-11
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
healthy controls	PET imaging	-

Primary Outcome Measures

Name	Time	Method
PET/MRI Brain Activation	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States