CannabisNCT06098573
Development and Evaluation of HighAlert
A study testing High Alert, Information condition and No contact in people with Cannabis and Youth Drinking, run by Western University, Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Cannabis, Youth Drinking
- What is being tested?
- High Alert, Information condition and No contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2023to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Individuals under 18 and those over 24
- resides outside Ontario
- non-drivers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of 'High Alert', a Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth
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.
- Conditions
- Cannabis, Youth Drinking
- Being tested
- High Alert, Information condition, No contact
- Medical subject headings
- Marijuana Abuse, Underage Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High AlertBehavioural
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
Information conditionBehavioural
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.
No contactBehavioural
Participants in the passive control will receive no contact until the three and six-month follow-ups.
| Study group | Role | What they receive |
|---|---|---|
| Program 1: High Alert | Experimental | High Alert Receives: Behavioral: High Alert |
| Program 2: Information condition | Active comparator | Active Control- Information condition Receives: Behavioral: Information condition |
| No contact | Placebo comparator | Passive control- No contact Receives: Behavioral: No contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098573
- Sponsor's protocol ID
- 123368
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of 'High Alert', a Mobile-Based Brief Intervention to Reduce Driving Under the Influence of Cannabis Among Youth
- ClinicalTrials.gov ID
- NCT06098573
- Acronym / sponsor ID
- 123368
- Conditions
- Cannabis, Youth Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Program 1: High Alert | Experimental | Behavioral: High AlertHigh Alert |
| Program 2: Information condition | Active comparator | Behavioral: Information conditionActive Control- Information condition |
| No contact | Placebo comparator | Behavioral: No contactPassive control- No contact |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Individuals under 18 and those over 24
- resides outside Ontario
- non-drivers
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 |
|---|---|---|
| High AlertParticipants 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 | Behavioural | Program 1: High Alert |
| Information conditionParticipants 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. | Behavioural | Program 2: Information condition |
| No contactParticipants in the passive control will receive no contact until the three and six-month follow-ups. | Behavioural | No contact |
Primary outcome
Past driving under the influence of cannabis
Time frame: 3-months
"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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Alert, Information condition and No contact in people with Cannabis and Youth Drinking, run by Western University, Canada at 1 site in Canada.
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 6 inclusion and 3 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 15 Oct 2024. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Past driving under the influence of cannabis (time frame: 3-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.