NCT03297944

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 29, 2020

Completed
Last Updated

January 29, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

September 26, 2017

Results QC Date

October 31, 2019

Last Update Submit

January 17, 2020

Conditions

Psychomotor Impairment

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

All Participants

EXPERIMENTAL

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)

Interventions

Alprazolam 2mg (2ALP/PLC)DRUG

2mg alprazolam administered at night, placebo administered in the morning.

All Participants
Alprazolam 1mg (1ALP/PLC)DRUG

1mg alprazolam administered at night, placebo administered in the morning.

All Participants
Alprazolam 0.5mg (0.5ALP/PLC)DRUG

0.5mg alprazolam administered at night, placebo administered in the morning.

All Participants
Zolpidem 10mg (ZOL/PLC)DRUG

10mg alprazolam administered at night, placebo administered in the morning.

All Participants
Placebo (PLC/PLC)DRUG

Placebo administered at night, placebo administered in the morning.

All Participants
Alprazolam 1mg (PLC/ALC)DRUG

Placebo administered at night, 1mg alprazolam administered in the morning.

All Participants

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • valid driver's license
  • english-speaking and literate

You may not qualify if:

  • 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
  • regular use of tobacco products
  • current substance use disorder
  • clinically significant ECG
  • current ongoing psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center on Drug and Alcohol Research

Lexington, Kentucky, 40508, United States

Location

Related Publications (1)

  • 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.

    PMID: 39541522DERIVED

MeSH Terms

Conditions

Psychomotor Disorders

Interventions

AlprazolamZolpidem

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Marion Coe
Organization
University of Kentucky
mcoe07@gmail.com
859-257-6488

Study Officials

  • Marion Coe

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
Participants and outcomes assessors were masked with respect to each individual intervention.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctoral Candidate

Study Record Dates

First Submitted

September 26, 2017

First Posted

September 29, 2017

Study Start

September 15, 2017

Primary Completion

October 25, 2018

Study Completion

October 25, 2018

Last Updated

January 29, 2020

Results First Posted

January 29, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)