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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50DA018197 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Baylor College of Medicine | OTHER |
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Psychostimulant dependence is a major public health problem and no medications have been shown to be very effective in treating this disorder. Thus, the investigators wish to study whether a blood pressure drug thought to reduce drug craving through its interaction at particular adrenergic receptors - doxazosin - can dredge cocaine use relative to placebo in psychostimulant dependent participants enrolled in an 8-week, randomized, double blind, placebo-controlled outpatient clinical trial. Our hypothesis is that doxazosin will reduce cocaine use relative to placebo in psychostimulant dependent participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxazosin | Experimental | Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial. |
|
| Placebo | Placebo Comparator | Participants will be maintained on placebo (cellulose) throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxazosin extended release | Drug | initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Psychostimulant-positive Urines Over Time | Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation. | twice-weekly urine samples (8 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Psychiatric Research Institute | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxazosin | Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
| FG001 | Placebo | Participants will be maintained on placebo (cellulose) throughout the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Those eligible participants who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxazosin | Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
| 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 | Change in Psychostimulant-positive Urines Over Time | Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation. | Those eligible participants who received at least one dose of study medication. | Posted | Mean | Standard Deviation | proportion of psychostimulant-pos urines | twice-weekly urine samples (8 weeks) | Urine samples | Participants |
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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 | Doxazosin | Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Oliveto, PhD | University of Arkansas for Medical Sciences | 501-526-8441 | olivetoalison@uams.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| non study related adverse event |
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| Blood Pressure outside study parameters |
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| BG001 | Placebo | Participants will be maintained on placebo (cellulose) throughout the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Participants will be maintained on placebo (cellulose) throughout the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. |
|
|
|
| 1 |
| 11 |
| 8 |
| 11 |
| EG001 | Placebo | Participants will be maintained on placebo (cellulose) throughout the trial. Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial. | 0 | 11 | 4 | 11 |
| Numbness in fingertips | Nervous system disorders | Systematic Assessment |
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| nausea, abdominal cramps | Gastrointestinal disorders | Systematic Assessment |
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| black eye | Eye disorders | Systematic Assessment |
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| palpitations with shortness of breath | Psychiatric disorders | Systematic Assessment |
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| Drowsiness, Fatigue | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Head edema from fight | Blood and lymphatic system disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
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| Sleep Disturbances | General disorders | Systematic Assessment |
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| Elevated blood pressure | Cardiac disorders | Systematic Assessment |
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| Abdominal pain and pain on urinating | Renal and urinary disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Orthostatic Hypotension | Cardiac disorders | Systematic Assessment |
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| Lightheadedness, dizziness | General disorders | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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