A Phase 4 interventional study of Alprazolam 2mg (2ALP/PLC) and Alprazolam 1mg (1ALP/PLC) in Psychomotor Impairment, sponsored by Marion Coe. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Marion Coe · Phase 4, Interventional, and Other
Among 15 studies in Psychomotor Disorders with a site in United States — 5 open to participants now, 7 under way, none of them phase 3. Psychomotor Disorders · United States.
Among the 15 studies in Psychomotor Disorders with a site in United States, this one is the only one that started in 2017, is one of 3 in phase 4, and was the 5th registered.
51 studies on the registry are indexed under Psychomotor Disorders; 8 are open to participants now.
Browse Psychomotor Disorders studies →5 of the 15 studies in Psychomotor Disorders with a site in United States are open now. Recruiting first, the newest first:
Ohio State University · Sites in United States
Ages 1–6
Ohio State University · Sites in United States
Ages up to 10 days
University of Missouri-Columbia · Sites in United States
Ages 0–99
Emory University · Sites in United States
Ages 18–65
Shirley Ryan AbilityLab · Sites in United States
Ages 0 days–52 wk
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Psychomotor Disorders studies recruiting now, none set no upper age limit and 5 stop at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
15 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 59 across 36 interventional studies indexed under Psychomotor Disorders.
Median enrollment 60 across the 9 interventional studies, 50 across the 5 observational. Of the 8 that completed or were terminated, 3 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 15 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Marion Coe as lead sponsor.
Marion Coe has 1 study filed under Psychomotor Disorders — fewer than ten, so there is no comparison to draw.
4 of the studies in Psychomotor Disorders with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03770832Shirley Ryan AbilityLabWearable Sensors and Video Recordings to Monitor Motor Development | 2026-12 |
| NCT05568264Shirley Ryan AbilityLabEffects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit | 2026-12-31 |
| NCT06399952University of Missouri-ColumbiaBaker Gordon Syndrome Natural History Study | 2027-05-05 |
| NCT05849038Emory UniversityInflammation and Depression in People With HIV | 2027-11 |
Add all 4 to your calendar (.ics) → With an account.
Among the 15 studies in Psychomotor Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants received each intervention with alprazolam, zolpidem and placebo.
Drug: Alprazolam 2mg (2ALP/PLC) · Drug: Alprazolam 1mg (1ALP/PLC) · Drug: Alprazolam 0.5mg (0.5ALP/PLC) · Drug: Zolpidem 10mg (ZOL/PLC) · Drug: Placebo (PLC/PLC) · Drug: Alprazolam 1mg (PLC/ALC)
Drug page: Alprazolam
2mg alprazolam administered at night, placebo administered in the morning.
Drug page: Alprazolam
1mg alprazolam administered at night, placebo administered in the morning.
Drug page: Alprazolam
0.5mg alprazolam administered at night, placebo administered in the morning.
Drug page: Zolpidem
10mg alprazolam administered at night, placebo administered in the morning.
Placebo administered at night, placebo administered in the morning.
Drug page: Alprazolam
Placebo administered at night, 1mg alprazolam administered in the morning.
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.
Time frame: 16 hours
| Milestone | All Participants |
|---|---|
| Started | 15 |
| 2alp/plc | 15 |
| 1alp/plc | 15 |
| 0.5alp/plc | 15 |
| Zol/plc | 15 |
| Plc/plc | 15 |
| Plc/alp | 15 |
| Completed | 15 |
| Not completed | 0 |
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
| distance (cm) | All Participants |
|---|---|
| 2ALP/PLC | 40.08 (28.1 to 68.1) |
| 1ALP/PLC | 37.28 (28.0 to 54.9) |
| 0.5ALP/PLC | 36.06 (27.6 to 53.7) |
| ZOL/PLC | 37.61 (28.3 to 65.6) |
| PLC/PLC | 36.30 (29.7 to 58.9) |
| PLC/ALP | 40.72 (28.5 to 68.7) |
Collected over 16 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2ALP/PLC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| 1ALP/PLC | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| 0.5ALP/PLC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| ZOL/PLC | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| PLC/PLC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| PLC/ALP | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | 2ALP/PLC | 1ALP/PLC | 0.5ALP/PLC | ZOL/PLC | PLC/PLC | PLC/ALP |
|---|---|---|---|---|---|---|
| HeadacheGeneral disorders | 0/15 | 1/15 | 0/15 | 1/15 | 0/15 | 0/15 |
| Stomach AcheGastrointestinal disorders | 0/15 | 0/15 | 0/15 | 1/15 | 0/15 | 0/15 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 30.53 ± 8.18 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Oct 2018, 13 months.
Results were first posted in Jan 2020, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alprazolam