NCT05537116

Brief Summary

Substance-Impaired Driving among emerging adults remains a significant public health concern and may be the single riskiest substance-related outcome among young adults. Brief Interventions (BIs) have been shown to reduce alcohol-impaired driving among this age group, but are not often implemented - despite their demonstrated efficacy - because it is not economically feasible to deliver in-person BIs to all emerging adult substance users. The present study will be the first to examine whether a text-messaging-based cannabis-impaired driving BI significantly decreases cannabis-impaired driving among emerging adult cannabis users compared to an informational control. Participants will be 240 emerging adults who endorse driving after cannabis use (or combined alcohol and cannabis use) at least three times in the past 3 months. After completing baseline measures, participants will be randomly assigned to receive either: a) substance use information, b) a substance-impaired driving personalized feedback intervention, or c) a substance-impaired driving personalized feedback intervention plus interactive text messages. Participants will complete outcome measures 3 and 6 months post-intervention. Repeated measures mixed modeling analyses will be used to determine whether the intervention significantly reduces substance-impaired driving over time. The project has two specific aims: 1) to evaluate a text based cannabis-impaired driving intervention in a randomized clinical trial, and 2) to determine whether the use of interactive text-messages sustains intervention effects over time.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

3.5 years

First QC Date

September 8, 2022

Last Update Submit

August 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Driving after cannabis use

    Number of times driving after cannabis use in the past 3 months

    3 and 6 months post-intervention

Secondary Outcomes (1)

  • Driving after combined alcohol and cannabis use

    3 and 6 months post-intervention

Other Outcomes (4)

  • Peer norms

    3 and 6 months post-intervention

  • Perceived dangerousness

    3 and 6 months post-intervention

  • Perceived consequences

    3 and 6 months post-intervention

  • +1 more other outcomes

Study Arms (3)

Personalized Feedback

EXPERIMENTAL

Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed).

Behavioral: Personalized feedback

Personalized feedback and text messages

EXPERIMENTAL

Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions.

Behavioral: Personalized feedback and text messages

Information only

ACTIVE COMPARATOR

Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message.

Behavioral: Information Only

Interventions

Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed).

Personalized Feedback

Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions.

Personalized feedback and text messages

Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message.

Information only

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 or older
  • Ability to speak, read, and write in English
  • Reports driving after using cannabis prior to driving at least three times in the past three months
  • Reports having access to a motor vehicle, a valid driver's license, and plans to drive a vehicle in the next 6 months
  • Reports access to a cell phone and willingness to read intervention material and exchange 3 texts post intervention with the study administrator
  • Reports a valid email address

You may not qualify if:

  • Currently in treatment for substance use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kelly Thompson Hall

Bowling Green, Kentucky, 42101, United States

Location

Study Officials

  • Jenni Teeters, PhD

    Western Kentucky University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to conditions using a random number generator.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

September 13, 2022

Study Start

October 18, 2022

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The final dataset will consist of self-reported data from survey questionnaires and qualitative data from text-messaging sessions. Preliminary data will be shared via a presentation at a national conference in the second and third years of the project. After all data is collected, a manuscript detailing findings from the study will be submitted for peer-review and de-identified data will be submitted to the NIDA data archive.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After all data is collected, a manuscript detailing findings from the study will be submitted for peer-review and de-identified data will be submitted to the NIDA data archive.

Locations