ClinicalTrials.gg
CompletedNCT06098573Updated Oct 15, 2024

Development and Evaluation of HighAlert

An interventional study of High Alert and Information condition in Cannabis and Youth Drinking, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Western University, Canada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
18 Years to 24 Years
Sex
All
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Study summary

In Canada, youth ages 16-24 have the highest rates of cannabis use, impaired driving, and express the least concern for driving under the influence of cannabis (DUIC). As such, developing effective and practical DUIC prevention efforts is crucial. This study aims to evaluate the effects of 'High Alert' in reducing 3-month risky cannabis use and DUIC among young Ontarian drivers. 'High Alert' is an interactive web-based smartphone application developed by the research team with the feedback of experts and youth. 'High Alert' modules focus on recognizing what constitutes risky cannabis use, the effects of cannabis on driving, the risks of DUIC, and strategies to avoid DUIC. A pilot randomized controlled trial will compare the effects of 'High Alert' with an active control (DUIC Information) and passive control (no contact). Overall, effectively preventing DUIC among youth is critically needed and time-sensitive.

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Conditions studied

  • Cannabis
  • Youth Drinking

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03

In context

Underage Drinking

44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.

This study's enrollment of 103 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.

Browse Underage Drinking studies →

Lead sponsor

Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • ages 18-24
  • valid Ontario driver's license
  • access to a motor vehicle
  • report DUIC at least three times in the past three months
  • proficient in English
  • have a smartphone they can complete the intervention with.

Exclusion criteria

Exclusion Criteria:

  • Individuals under 18 and those over 24
  • resides outside Ontario
  • non-drivers
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
103 participants (actual)

Study arms

  • Experimental
    Program 1: High Alert

    High Alert

    Behavioral: High Alert

  • Active comparator
    Program 2: Information condition

    Active Control- Information condition

    Behavioral: Information condition

  • Placebo comparator
    No contact

    Passive control- No contact

    Behavioral: No contact

Interventions

  • BehavioralHigh Alert

    Participants assigned to the 'High Alert' condition will complete four interactive modules using their smartphones. These modules are hosted online via the Computerized Intervention Authoring Software, version 3.0 (https://www.cias.app \[CIAS\]). CIAS is a non- commercial, easily modifiable, web-based intervention platform used widely in the digital substance use literature. No identifiable information is requested or stored in CIAS. This program is only intended to deliver the content interactively. None of the questions asked in CIAS will be treated as research data. We will only report on the proportion of questions answered by participants (as a measure of adherence). Individual responses to questions will not be analyzed nor reported on. The purpose of the questions is for participants to engage with the content interactively

  • BehavioralInformation condition

    Participants in the DUIC Information condition will receive a Qualtrics link with six infographics created to educate about DUIC. Four infographics were retrieved from government websites, one was provided by a non-profit (i.e., Arrive Alive Drive Sober), and the research team created the final one. After reviewing each infographic, participants will respond to a few questions about the infographic. Questions asked to the DUIC Info Control will obtain data related to: seeing the infographic before, perceptions on the infographic content, aspects they liked/disliked, and likelihood to share with their peers. All items will be treated as research data.

  • BehavioralNo contact

    Participants in the passive control will receive no contact until the three and six-month follow-ups.

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What researchers measure

Primary outcomes

  1. Past driving under the influence of cannabis

    "in the past three months, how many times have you driven within two hours of inhaling cannabis or within four hours of ingesting cannabis". Continuous variable (min=0, no maximum). Higher numbers indicate worse outcome (i.e., more impaired driving).

    Time frame: 3-months

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Study locations

1 site
  • Western University
    London, Ontario N6G 1G9, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in Sep 2024, 10 months.

Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 10 months is below that.

Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2023
First posted
Oct 24, 2023
StartActual
Nov 1, 2023
Primary completionActual
Sep 10, 2024
CompletionActual
Sep 10, 2024
Last update
Oct 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06098573
Responsible party
Sponsor
First posted
Oct 24, 2023
Start date
Nov 1, 2023
Primary completion
Sep 10, 2024
Completion
Sep 10, 2024
Last update
Oct 15, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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