NCT01999530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 17, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

2.8 years

First QC Date

November 26, 2013

Results QC Date

August 30, 2018

Last Update Submit

May 17, 2019

Conditions

Healthy

Keywords

prazosindopaminehealthyPositron Emission TomographyPHNOscaneffect

Outcome Measures

Primary Outcomes (1)

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

    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

    3 weeks after taking prazosin

Study Arms (1)

Prazosin Hydrochloride

EXPERIMENTAL

Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks.

Drug: Prazosin Hydrochloride

Interventions

Prazosin HydrochlorideDRUG

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

Also known as: Teva-Prazosin, Prazosin, Minipress
Prazosin Hydrochloride

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

MeSH Terms

Interventions

Prazosin

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Bernard Le Foll
Organization
Centre for Addiction and Mental Health
bernard.lefoll@camh.ca
416-535-8501

Study Officials

  • Bernard Le Foll, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 3, 2013

Study Start

November 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 30, 2019

Results First Posted

May 17, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Publication Access

Locations

CA(1)