Trial Outcomes & Findings for Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim (NCT NCT04970342)
NCT ID: NCT04970342
Last Updated: 2023-07-25
Results Overview
The ability to keep the vehicle straight in the lane. Data is presented from the a rural drive with a concurrent divided attention task.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3
Results posted on
2023-07-25
Participant Flow
Of the 13 subjects enrolled, 8 were randomized to one of six sequences counterbalancing the three treatment arms. Subjects were randomized at intake for Treatment Visit 1. Of the 5 subjects enrolled but not randomized, 3 did not meet study criteria at the screening visit, 1 had scheduling conflicts, and 1 failed to show for Treatment Visit 1. There was a minimum 7-day washout between the Screening Visit and intake for Treatment Visit 1. All randomized subjects completed all treatment arms.
Participant milestones
| Measure |
Sequence 1
Treatment Visit 1: Experimental: "Sober" or Double Placebo Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 2: Experimental: Active Alprazolam (Xanax), Placebo Cannabis Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 3: Experimental: Placebo Alprazolam (Xanax), Active Cannabis Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
|
Sequence 2
Treatment Visit 1: Experimental: Active Alprazolam (Xanax), Placebo Cannabis Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 2: Experimental: Placebo Alprazolam (Xanax), Active Cannabis Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Treatment Visit 3: Experimental: "Sober" or Double Placebo Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
|
Sequence 3
Treatment Visit 1: Experimental: Placebo Alprazolam (Xanax), Active Cannabis Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Treatment Visit 2: Experimental: "Sober" or Double Placebo Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 3: Experimental: Active Alprazolam (Xanax), Placebo Cannabis Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
|
Sequence 4
Treatment Visit 1: Experimental: "Sober" or Double Placebo Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 2: Experimental: Placebo Alprazolam (Xanax), Active Cannabis Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Treatment Visit 3: Experimental: Active Alprazolam (Xanax), Placebo Cannabis Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
|
Sequence 5
Treatment Visit 1: Experimental: Active Alprazolam (Xanax), Placebo Cannabis Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 2: Experimental: "Sober" or Double Placebo Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 3: Experimental: Placebo Alprazolam (Xanax), Active Cannabis Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
|
Sequence 6
Treatment Visit 1: Experimental: Placebo Alprazolam (Xanax), Active Cannabis Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Treatment Visit 2: Experimental: Active Alprazolam (Xanax), Placebo Cannabis Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
Treatment Visit 3: Experimental: "Sober" or Double Placebo Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
|
|---|---|---|---|---|---|---|
|
Treatment Visit 1 (1 Day)
STARTED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Treatment Visit 1 (1 Day)
COMPLETED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Treatment Visit 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout (7 Days)
STARTED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Washout (7 Days)
COMPLETED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Washout (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Visit 2 (1 Day)
STARTED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Treatment Visit 2 (1 Day)
COMPLETED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Treatment Visit 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Visit 3 (1 Day)
STARTED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Treatment Visit 3 (1 Day)
COMPLETED
|
2
|
2
|
1
|
1
|
1
|
1
|
|
Treatment Visit 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of the Drug Impaired Driving Scenario (DIDS) on the CRCDS-miniSim
Baseline characteristics by cohort
| Measure |
Randomized Subjects
n=8 Participants
Summary of all subjects randomized. All randomized subjects completed all study arms across three treatment visits.
"Sober" or Double Placebo: Subject received alprazolam capsule containing placebo (lactose) and 40 minutes later received placebo cannabis (0% THC / 0% CBD).
Active Alprazolam (Xanax), Placebo Cannabis: Subject received active 0.75 mg alprazolam capsule and 40 minutes later received placebo cannabis (0% THC / 0% CBD).
Placebo Alprazolam (Xanax), Active Cannabis: Subject received alprazolam capsule containing placebo (lactose) and 40 minutes later received active cannabis (6.18% THC / \<0.025% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three visits, orally administered 40 minutes prior to cannabis dose.
0.75 mg Alprazolam Capsule: Single dose on one of the three visits, orally administered 40 minutes prior to cannabis dose.
Cannabis (0%/ THC / 0% CBD): Cannabis vapor was produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects inhaled using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three visits.
Cannabis (6.18% THC / \<0.025% CBD): Cannabis vapor was produced from 500 mg of dried plant material (6.18% THC / \<0.025% CBD). Subjects inhaled using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three visits.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3Population: All Subjects
The ability to keep the vehicle straight in the lane. Data is presented from the a rural drive with a concurrent divided attention task.
Outcome measures
| Measure |
"Sober" or Double Placebo
n=8 Participants
Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (0%/ THC / 0% CBD): Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
|
Active Alprazolam (Xanax), Placebo Cannabis
n=8 Participants
Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
0.75 mg Alprazolam Capsule: Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (0%/ THC / 0% CBD): Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
|
Placebo Alprazolam (Xanax), Active Cannabis
n=8 Participants
Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (6.18% THC / \<0.025% CBD): Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / \<0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.
|
|---|---|---|---|
|
Standard Deviation of Lateral Position (SDLP)
|
25.490 cm
Standard Deviation 5.737
|
37.849 cm
Standard Deviation 6.434
|
33.086 cm
Standard Deviation 12.375
|
SECONDARY outcome
Timeframe: over one hour during the course of the simulator drive conducted 45 minutes post-dose at Treatment Visit 1, 2, and 3Population: All subjects
Count of the number of times the simulated vehicle leaves the driving lane, will be compared across treatments. Data is from a rural drive with a concurrent divided attention task.
Outcome measures
| Measure |
"Sober" or Double Placebo
n=8 Participants
Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (0%/ THC / 0% CBD): Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
|
Active Alprazolam (Xanax), Placebo Cannabis
n=8 Participants
Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
0.75 mg Alprazolam Capsule: Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (0%/ THC / 0% CBD): Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
|
Placebo Alprazolam (Xanax), Active Cannabis
n=8 Participants
Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (6.18% THC / \<0.025% CBD): Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / \<0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.
|
|---|---|---|---|
|
Lane Exceedences
|
5.750 number of times vehicle departed lane
Standard Deviation 6.251
|
36.500 number of times vehicle departed lane
Standard Deviation 19.413
|
29.875 number of times vehicle departed lane
Standard Deviation 48.147
|
Adverse Events
"Sober" or Double Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Active Alprazolam (Xanax), Placebo Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Alprazolam (Xanax), Active Cannabis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
"Sober" or Double Placebo
n=8 participants at risk
Subject receives alprazolam capsule containing placebo (lactose). Subject receives placebo cannabis (0% THC / 0% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (0%/ THC / 0% CBD): Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
|
Active Alprazolam (Xanax), Placebo Cannabis
n=8 participants at risk
Subject receives active 0.75 mg alprazolam capsule. Subject receives placebo cannabis (0% THC / 0% CBD).
0.75 mg Alprazolam Capsule: Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (0%/ THC / 0% CBD): Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
|
Placebo Alprazolam (Xanax), Active Cannabis
n=8 participants at risk
Subject receives alprazolam capsule containing placebo (lactose). Subject receives active cannabis (6.18% THC / \<0.025% CBD).
Placebo (Lactose) Capsule: Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
Cannabis (6.18% THC / \<0.025% CBD): Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / \<0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Duration of study participation. Adverse Events were captured from the time of enrollment to the time of study follow-up, a maximum duration of 5 weeks.
|
0.00%
0/8 • Duration of study participation. Adverse Events were captured from the time of enrollment to the time of study follow-up, a maximum duration of 5 weeks.
|
0.00%
0/8 • Duration of study participation. Adverse Events were captured from the time of enrollment to the time of study follow-up, a maximum duration of 5 weeks.
|
Additional Information
Timothy Brown, Ph.D.
National Advanced Driving Simulator, University of Iowa
Phone: 3193354785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The PIs must coordinate with the government (sponsor).
- Publication restrictions are in place
Restriction type: OTHER