Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06098573
Other study ID # 123368
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date September 1, 2024

Study information

Verified date December 2023
Source Western University, Canada
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date September 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion: - 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: - Individuals under 18 and those over 24 - resides outside Ontario - non-drivers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
High 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
Information 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.
No contact
Participants in the passive control will receive no contact until the three and six-month follow-ups.

Locations

Country Name City State
Canada Western University London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 3-months
See also
  Status Clinical Trial Phase
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT04199468 - THC and Ketamine Effects in Humans: Relation to Neural Oscillations and Psychosis Phase 1
Completed NCT04587700 - Analgesic Consumption in Chronic Marijuana Users Following Orthopedic Trauma Surgery
Not yet recruiting NCT05899946 - An Integrated Program to Promote Anti-cannabis Messages N/A
Active, not recruiting NCT02735954 - Colorado Marijuana Users Health Cohort
Completed NCT00842985 - Dronabinol Interactions in Humans N/A
Completed NCT04124432 - Behavioral Pharmacology of Cannabis and Nicotine Phase 1
Active, not recruiting NCT04693884 - Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise Early Phase 1
Recruiting NCT03078309 - The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients Early Phase 1
Active, not recruiting NCT03560934 - Tetrahydrocannabinol (THC) and Sleep Early Phase 1
Recruiting NCT04704271 - Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study II Phase 1
Withdrawn NCT03245658 - The Effect of Cannabis in Pancreatic Cancer Phase 2
Completed NCT04911127 - Therapeutic Response of Cannabidiol in Rheumatoid Arthritis Phase 1
Not yet recruiting NCT05999383 - Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration Phase 2
Recruiting NCT04429568 - THC Crossover Study N/A
Completed NCT05554146 - Pain Inflammation and Cannabis in HIV N/A
Not yet recruiting NCT05320367 - A Study of Inhaled Cannabidiol in Healthy Occasional Cannabis Users Phase 1/Phase 2
Completed NCT02567344 - Excitatory rTMS to the Left Dorsolateral Pre-Frontal Cortex to Reduce Cannabis-Cue Induced Craving N/A
Terminated NCT03251326 - Nabilone in Cannabis Users With PTSD Phase 1/Phase 2
Completed NCT00176085 - Pharmacokinetics of THCCOOH and Its Acyl-glucuronide After Intravenous Administration of THCCOOH Phase 1