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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| VA Puget Sound Health Care System | FED |
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The purpose of the study is to evaluate if the drug prazosin:
The proposed study is a 19-week, titration to stable dose, randomized, two-group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size will be greater in Service Members with PTSD than without PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prazosin hydrochloride | Active Comparator | Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. |
|
| placebo | Placebo Comparator | Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prazosin hydrochloride | Drug | study drug arm prazosin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Penn Alcohol Craving Scale Score | Penn Alcohol Craving Scale (PACS) The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving. | Change at Week 13 from Baseline |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Murray Raskind, MD | Department of Veterans Affairs Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Madigan Army Medical Center | Tacoma | Washington | 98431 | United States |
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Active duty soldiers participating in command mandated Army outpatient alcohol treatment were randomized to the brain-penetrant alpha-1 adrenergic receptor antagonist prazosin or placebo for 13 weeks.
The period of enrollment and completion of study procedures was January, 2015, through July, 2018.
The study was ended following enrollment of 158 participants due to end of funding.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prazosin Hydrochloride | Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 26, 2020 |
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| placebo | Drug | study drug arm placebo |
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| Placebo |
Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prazosin Hydrochloride | Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin |
| BG001 | Placebo | Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Change in Penn Alcohol Craving Scale Score | Penn Alcohol Craving Scale (PACS) The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving. | Posted | Mean | Standard Error | units on a scale | Change at Week 13 from Baseline |
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Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks.
This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
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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 | Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin | 0 | 46 | 2 | 46 | 44 | 46 |
| EG001 | Placebo | Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo | 0 | 56 | 1 | 56 | 52 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skull fracture and subdural hematoma | General disorders | Non-systematic Assessment | One participant randomized to placebo suffered a fractured skull and subdural hematoma resulting from a fall while alcohol intoxicated. |
| |
| Suicidal Ideation | Psychiatric disorders | Non-systematic Assessment | One participant was psychiatrically hospitalized for suicidal ideation. |
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| anxiety associated with occupational stressors | Psychiatric disorders | Non-systematic Assessment | One participant was hospitalized due to anxiety associated with occupational stressors. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness on standing | General disorders | Systematic Assessment |
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| Nasal Congestion | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
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| Weakness | General disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Peripheral edema | General disorders | Systematic Assessment |
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| Depressed Mood | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murray Raskind, MD | VA Puget Sound Health Care System | (206) 277-3797 | Murray.Raskind@va.gov |
| Nov 4, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D011224 | Prazosin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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