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| Name | Class |
|---|---|
| Ontario Lung Association | OTHER |
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prazosin Hydrochloride | Experimental | Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prazosin Hydrochloride | Drug | Gradual upward titration to 15mg/day for approximately three weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Addiction and Mental Health | Toronto | Ontario | M5T 1R8 | Canada |
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| Label | URL |
|---|---|
| Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Publication | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prazosin Hydrochloride | Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks. Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prazosin Hydrochloride | Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks. Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Full Range | binding potential | 3 weeks after taking prazosin |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prazosin Hydrochloride | Gradual upward titration to 15mg/day (or highest dose tolerated) for approximately three weeks. Prazosin Hydrochloride: Gradual upward titration to 15mg/day for approximately three weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Adverse events caused by prazosin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard Le Foll | Centre for Addiction and Mental Health | 416-535-8501 | 34772 | bernard.lefoll@camh.ca |
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| ID | Term |
|---|---|
| D011224 | Prazosin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| 0 |
| 20 |
| 6 |
| 20 |
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