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Trial record 1 of 1 for:    NCT01999530
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The Effects of Prazosin on Dopamine in Healthy Humans: A PET Pilot Study

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ClinicalTrials.gov Identifier: NCT01999530
Recruitment Status : Completed
First Posted : December 3, 2013
Results First Posted : May 17, 2019
Last Update Posted : May 30, 2019
Sponsor:
Collaborators:
Ontario Lung Association
Pfizer
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health

Tracking Information
First Submitted Date  ICMJE November 26, 2013
First Posted Date  ICMJE December 3, 2013
Results First Submitted Date  ICMJE August 30, 2018
Results First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2013)
Changes in [11C]-(+)-PHNO binding [ Time Frame: 0, 3 weeks, 1 week washout ]
Outcome measure occurs before taking medication, after 3 weeks of medication, and after washout of about one week (+/- a few days)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Prazosin on Dopamine in Healthy Humans: A PET Pilot Study
Official Title  ICMJE Exploring the Effects of Prazosin on Basal Dopamine in Healthy Humans: A [11C]-(+)-PHNO PET Pilot Study
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Prazosin Hydrochloride
Gradual upward titration to 15mg/day for approximately three weeks.
Other Names:
  • Teva-Prazosin
  • Prazosin
  • Minipress
Study Arms  ICMJE Experimental: Prazosin Hydrochloride
Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks.
Intervention: Drug: Prazosin Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2019)
20
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
6
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01999530
Other Study ID Numbers  ICMJE 224/2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bernard Le Foll, Centre for Addiction and Mental Health
Study Sponsor  ICMJE Centre for Addiction and Mental Health
Collaborators  ICMJE
  • Ontario Lung Association
  • Pfizer
Investigators  ICMJE
Principal Investigator: Bernard Le Foll, MD, PhD Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP