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Completed

NCT Number: NCT01546155

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.

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Key information

Conditions

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02139, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET Imaging

Radiation

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2015
First posted
Mar 7, 2012
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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