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Completed

NCT Number: NCT01999530

The Effects of Prazosin on Dopamine in Healthy Humans: A PET Pilot Study

The purpose of this study is to find out whether short term treatment with a antihypertensive medication prazosin, can influence the levels of a dopamine in the brain. We will examine the levels of dopamine in the the brain using Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). We hypothesize that there will be no significant changes in dopamine levels in healthy individuals taking prazosin.

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Key information

Conditions

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

About this study

The purpose of this study is to find out whether short term treatment with a antihypertensive medication prazosin, can influence the levels of dopamine in the brain. We will examine the levels of dopamine in the the brain using Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI). The study will involve three PET scans and one MRI. One PET scan will be performed before the participants take prazosin for approximately three weeks, and the last two PET scans will be performed after the prazosin medication phase. We hypothesize that there will be no significant changes in dopamine levels in healthy individuals taking prazosin.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males and females of any ethnic origin between 19 and 45 years old

Exclusion criteria

  • Use of any illicit drugs in past 3 months prior to randomization and/or have a current or past diagnosis of drug abuse/dependence (including alcohol)
  • Current or past DSM-IV diagnosis of any Axis I psychiatric disorder
  • Major psychiatric illness and/or substance dependence in first order relatives
  • Current active or past suicidal ideation
  • Baseline systolic blood pressure outside the normal range
  • Current use of medications that could interact with prazosin (e.g. beta blockers, phosphodiesterasetype 5 inhibitors, indomethacin, verapamil, modafinil, clonidine)
  • Current use or use during the previous month of medication that may affect the CNS at the time of scanning (e.g. neuroleptics, bupropion)
  • Any significant abnormalities in baseline blood results (e.g. CBC, renal and hepatic indicators) or ECG readings that would preclude the use of prazosin
  • Pregnancy, trying to become pregnant or breastfeeding
  • Presence of metal objects in the body (e.g. some artificial joints, bone pins, surgical clips, skull plate, certain part of dental braces) or implanted electronic devices (e.g. cardiac pacemaker, neurostimulator), that preclude safe MR scanning
  • Claustrophobia
  • Participation in any nuclear medicine procedures that, including the dose received during participation in this study, will bring the total radiation dose over the currently approved guideline of 20mSv in a 12-month period
  • Cardiovascular or cerebrovascular diseases
  • History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor
  • Abnormal body mass (defined as not within 20% of normal BMI
  • Learning disability, amnesia or other conditions that impede memory and attention

Treatment and study plan

Prazosin hydrochloride

Drug

Gradual upward titration to 15mg/day for approximately three weeks.

Other names: Teva-Prazosin, Prazosin, Minipress

Primary outcomes

  1. Changes in [11C]-(+)-PHNO Binding (Measured as Binding Potential) in Dorsal Caudate (DC)

    Time frame: 3 weeks after taking prazosin

    Binding potential (an estimate of the ratio of Bmax/kd) was measured by positron emission tomography to determine if taking prazosin alters the amount of tracer bound to receptors. A negative change in binding potential means a decrease in binding potential and a positive change in binding potential represents an increase. Bmax is the total density of receptors. kd is the affinity of a drug for the target

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Ontario Lung Association
  • Pfizer

Registry information

Official study title

Exploring the Effects of Prazosin on Basal Dopamine in Healthy Humans: A [11C]-(+)-PHNO PET Pilot Study

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2013
Registry last updated
May 30, 2019

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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