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

NCT ID: NCT01999530

Last Updated: 2019-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Prazosin Hydrochloride

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

Group Type: EXPERIMENTAL

Prazosin Hydrochloride

Intervention Type: DRUG

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

Interventions

Prazosin Hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

Teva-Prazosin; Prazosin; Minipress

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ontario Lung Association

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Bernard Le Foll

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard Le Foll, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Study Documents

Document Type: Publication

View Document

Related Links

http://www.camh.net/research

Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching

Other Identifiers

224/2012

Identifier Type: -

Identifier Source: org_study_id