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| ID | Type | Description | Link |
|---|---|---|---|
| R36DA043714-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | All participants received each intervention with alprazolam, zolpidem and placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alprazolam 2mg (2ALP/PLC) | Drug | 2mg alprazolam administered at night, placebo administered in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lane Position (SLDP) | Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane. | 16 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marion Coe | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center on Drug and Alcohol Research | Lexington | Kentucky | 40508 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39541522 | Derived | Roszkowski SC, Babalonis S, Coe MA, Nuzzo PA, Lofwall MR, Fanucchi LC, Walsh SL. Residual next-day effects of alprazolam on psychomotor performance and simulated driving in healthy normal adults. Exp Clin Psychopharmacol. 2025 Apr;33(2):178-188. doi: 10.1037/pha0000746. Epub 2024 Nov 14. |
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All 15 participants received every intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants received all six interventions; combinations of placebo (PLC), alprazolam (ALP) or zolpidem (ZOL). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All 15 participants received each intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Standard Deviation of Lane Position (SLDP) | Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane. | All 15 participants received each intervention. | Posted | Mean | Full Range | distance (cm) | 16 hours |
|
|
16 hours
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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 | 2ALP/PLC | 2mg Alprazolam administered at night, placebo administered in the morning Alprazolam: 0.5 to 2mg administered at night or in the morning |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marion Coe | University of Kentucky | 859-257-6488 | mcoe07@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2017 | Sep 13, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2017 | Sep 13, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D011596 | Psychomotor Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Participants and outcomes assessors were masked with respect to each individual intervention.
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| Alprazolam 1mg (1ALP/PLC) | Drug | 1mg alprazolam administered at night, placebo administered in the morning. |
|
| Alprazolam 0.5mg (0.5ALP/PLC) | Drug | 0.5mg alprazolam administered at night, placebo administered in the morning. |
|
| Zolpidem 10mg (ZOL/PLC) | Drug | 10mg alprazolam administered at night, placebo administered in the morning. |
|
| Placebo (PLC/PLC) | Drug | Placebo administered at night, placebo administered in the morning. |
|
| Alprazolam 1mg (PLC/ALC) | Drug | Placebo administered at night, 1mg alprazolam administered in the morning. |
|
| 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 |
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| Region of Enrollment | Count of Participants | Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 1ALP/PLC | 1mg Alprazolam administered at night, placebo administered in the morning Alprazolam: 0.5 to 2mg administered at night or in the morning | 0 | 15 | 0 | 15 | 1 | 15 |
| EG002 | 0.5ALP/PLC | 0.5mg Alprazolam administered at night, placebo administered in the morning Alprazolam: 0.5 to 2mg administered at night or in the morning | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | ZOL/PLC | 10mg Zolpidem administered at night, placebo administered in the morning Zolpidem: 10mg administered at night or in the morning | 0 | 15 | 0 | 15 | 2 | 15 |
| EG004 | PLC/PLC | Placebo administered at night, placebo administered in the morning Placebo: placebo administered at night and/or in the morning | 0 | 15 | 0 | 15 | 0 | 15 |
| EG005 | PLC/ALP | Placebo administered at night, 1mg alprazolam administered in the morning Alprazolam: 0.5 to 2mg administered at night or in the morning | 0 | 15 | 0 | 15 | 0 | 15 |
| Stomach Ache | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |