The Effects of Prazosin on Dopamine in Healthy Humans: A PET Pilot Study
NCT01999530
ABOUT THIS STUDY
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- Healthy males and females of any ethnic origin between 19 and 45 years old
- 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
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Descriptive Information | ||||
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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:
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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 | 20 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Bernard Le Foll, Centre for Addiction and Mental Health | |||
Study Sponsor ICMJE | Centre for Addiction and Mental Health | |||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |