Psychomotor ImpairmentPhase 4NCT03297944
Sedative-Anxiolytic Effects on Simulated Driving Performance
A Phase 4 study testing Alprazolam 2mg (2ALP/PLC), Alprazolam 1mg (1ALP/PLC) and Alprazolam 0.5mg (0.5ALP/PLC) in people with Psychomotor Impairment, run by Marion Coe at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychomotor Impairment
- What is being tested?
- Alprazolam 2mg (2ALP/PLC), Alprazolam 1mg (1ALP/PLC) and Alprazolam 0.5mg (0.5ALP/PLC)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 25 Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- valid driver's license
- english-speaking and literate
Who cannot join
- using daily medication for chronic condition
- acute narrow angle glaucoma
- previous adverse experience with study drugs
- experiences motion sickness in response to driving simulator
- BMI > 30
- women who are pregnant, lactating, or planning on becoming pregnant
Show all 10Show fewer
- regular use of tobacco products
- current substance use disorder
- clinically significant ECG
- current ongoing psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Center on Drug and Alcohol Research
Lexington, Kentucky, 40508
About this study
Official title: Alprazolam and Simulated Driving Performance: Next Day Effects
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.
- Conditions
- Psychomotor Impairment
- Being tested
- Alprazolam 2mg (2ALP/PLC), Alprazolam 1mg (1ALP/PLC), Alprazolam 0.5mg (0.5ALP/PLC), Zolpidem 10mg (ZOL/PLC), Placebo (PLC/PLC)
- Medical subject headings
- Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam 2mg (2ALP/PLC)Drug
2mg alprazolam administered at night, placebo administered in the morning.
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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | All participants received each intervention with alprazolam, zolpidem and placebo. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start15 Sep 2017
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychomotor ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marion Coe
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Marion Coe, University of Kentucky
- Investigators
- Marion Coe, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297944
- Sponsor's protocol ID
- 16-0260-F6A
- Other IDs
- R36DA043714-01A1
- Status last verified
- Jan 2020
- First submitted
- 26 Sep 2017
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39541522
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alprazolam and Simulated Driving Performance: Next Day Effects
- ClinicalTrials.gov ID
- NCT03297944
- Acronym / sponsor ID
- 16-0260-F6A
- Conditions
- Psychomotor Impairment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marion CoeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | 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)All participants received each intervention with alprazolam, zolpidem and placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- valid driver's license
- english-speaking and literate
Key exclusion criteria (10 listed)
- using daily medication for chronic condition
- acute narrow angle glaucoma
- previous adverse experience with study drugs
- experiences motion sickness in response to driving simulator
- BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alprazolam 2mg (2ALP/PLC)2mg alprazolam administered at night, placebo administered in the morning. | Drug | All Participants |
| Alprazolam 1mg (1ALP/PLC)1mg alprazolam administered at night, placebo administered in the morning. | Drug | All Participants |
| Alprazolam 0.5mg (0.5ALP/PLC)0.5mg alprazolam administered at night, placebo administered in the morning. | Drug | All Participants |
| Zolpidem 10mg (ZOL/PLC)10mg alprazolam administered at night, placebo administered in the morning. | Drug | All Participants |
| Placebo (PLC/PLC)Placebo administered at night, placebo administered in the morning. | Drug | All Participants |
| Alprazolam 1mg (PLC/ALC)Placebo administered at night, 1mg alprazolam administered in the morning. | Drug | All Participants |
Primary outcome
Standard Deviation of Lane Position (SLDP)
Time frame: 16 hours
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39541522Roszkowski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Coe principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprazolam 2mg (2ALP/PLC), Alprazolam 1mg (1ALP/PLC) and Alprazolam 0.5mg (0.5ALP/PLC) in people with Psychomotor Impairment, run by Marion Coe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Deviation of Lane Position (SLDP) (time frame: 16 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297944, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.