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

NCT ID: NCT01546155

Last Updated: 2017-04-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Healthy Controls

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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healthy controls

Group Type EXPERIMENTAL

PET imaging

Intervention Type RADIATION

Up to a 120 minute PET scan using \[11C\]diprenorphine as the radiotracer

Interventions

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PET imaging

Up to a 120 minute PET scan using \[11C\]diprenorphine as the radiotracer

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Kong, MD (equiv), MS, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2011P0022171

Identifier Type: -

Identifier Source: org_study_id

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