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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA018197-04 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse among cocaine dependent participants.
The NE system, especially the alpha 1-adrenergic receptor, may play an important role in cocaine addiction in humans. The results of this study will provide medical safety data on the duration of the induction schedule that will be optimal for attaining our target dose of 8 mg doxazosin daily and will guide future pharmacotherapy trials using Doxazosin or related alpha 1 receptor antagonists for cocaine addiction.
This 17-week double-blind, placebo controlled clinical trial includes a 13 week medication trial (weeks 1-13) and up to 4 week washout period(weeks 14-17). Qualifying subjects will be randomized to receive Doxazosin 8 mg/day, or placebo during the study participation.
Medication induction will occur at a rate of 2mg/week until 8mg/day target dose is achieved as follows:
Both groups will be tapered off doxazosin or placebo over study weeks 14-17.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doxazosin | Experimental | Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
Both groups were tapered off doxazosin or placebo over study weeks 14-17. |
|
| placebo | Placebo Comparator | A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxazosin | Drug | Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17. |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Negative Urines | cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine | throughout the study - up to 17 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weeks of Abstinence | Percentage of participants achieving 2 or more consecutive weeks of abstinence | throughout the study - up to 17 weeks |
| # of Participants That Completed the Study | Retention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas R Kosten, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine - Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
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Thirty-five subjects were randomized into the study, with 30 subjects returning and receiving at least one dose of medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doxazosin Fast | Participantsreaching the target dose after a 4-week titration period |
| FG001 | Doxazosin Slow | Participants reaching the target dose after an 8-week titration period |
| FG002 | Placebo | Matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cocaine dependent individuals = 17; Placebo = 13; 5 lost to followup. During analysis, an additional 2 individuals were dropped due from analyses due to invalidated data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Doxazosin Slow Titration | Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows: Dox-Slow Group: Participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin over weeks 8-13. Participants were tapered off doxazosin or placebo over study weeks 14-17. |
| 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 | Cocaine Negative Urines | cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine | Posted | Number | percentage of cocaine-negative urines | throughout the study - up to 17 weeks |
|
Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
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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 | Dox-Slow Group | Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches | Nervous system disorders | Systematic Assessment |
Initially the study randomized subjects into 2 conditions (placebo/DOX). After the observation that rapid titration was safe, a DOX-fast group was created. This did not allow for early participants to be randomized to the rapid titration condition.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Kosten, MD | Baylor College of Medicine | 713-794-7032 | kosten@bcm.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D017292 | Doxazosin |
| ID | Term |
|---|---|
| D011224 | Prazosin |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Other | Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication. |
|
|
| throughout the study - up to 17 weeks |
| Adverse Events | throughout study - upto 17 weeks |
| BG001 |
| Doxazosin Fast Titration |
Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows: Dox-Fast Group: Participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin over weeks 4-13. Participants were tapered off doxazosin or placebo over study weeks 14-17. |
| BG002 | Placebo | Participants received matched placebo during weeks 1-13. Participants were tapered off placebo over study weeks 14-17. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Employment | Employed over the past 3 years | Count of Participants | Participants |
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| Alcohol use - past 30 days | Mean | Standard Deviation | days |
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| Cocaine use - past 30 days | Mean | Standard Deviation | days |
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| OG002 | Placebo | Participants took placebo during weeks 1-17. |
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| Secondary | Weeks of Abstinence | Percentage of participants achieving 2 or more consecutive weeks of abstinence | Posted | Number | percentage of participants | throughout the study - up to 17 weeks |
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| Secondary | # of Participants That Completed the Study | Retention | Posted | Count of Participants | Participants | throughout the study - up to 17 weeks |
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| Secondary | Adverse Events | Posted | Number | events | throughout study - upto 17 weeks |
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|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Dox-Fast Group: | Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group) | 0 | 9 | 0 | 9 | 3 | 9 |
| EG002 | Placebo | A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration. Placebo: Placebo daily dosing | 0 | 13 | 0 | 13 | 3 | 13 |
| Dizinness | Cardiac disorders | Systematic Assessment |
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| Toothache | General disorders | Systematic Assessment |
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| D006571 | Heterocyclic Compounds |