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

Healthy research study

What is the primary objective of 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 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Prazosin HydrochlorideGradual upward titration to 15mg/day for approximately three weeks.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Completed

Start Date: November 2013

Completed Date: August 2016

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Changes in [11C]-(+)-PHNO binding

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Bernard Le Foll, MD, PhD

Lead Sponsor: Centre for Addiction and Mental Health

Collaborator: Ontario Lung Association

More information:https://clinicaltrials.gov/show/NCT01999530

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