Trial Outcomes & Findings for Evaluation of an Interactive Mobile Phone-Based Brief Intervention to Reduce Substance-Impaired Driving (NCT NCT05537116)
NCT ID: NCT05537116
Last Updated: 2026-08-31
Results Overview
Self-reported count of driving-after-cannabis-use episodes during the prior 3 months, assessed at the 3-month post-intervention follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
3-month post-intervention follow-up assessment
Results posted on
2026-08-31
Participant Flow
Lab personnel recruited emerging adults from communities surrounding Bowling Green, KY. Flyers were strategically placed around campus and around community locations frequented by emerging adults within 60 miles of campus. Additionally, targeted advertisements were placed on Facebook and Instagram.
Participant milestones
| Measure |
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. 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 and Text Messages
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.
|
Information Only
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
45
|
54
|
|
Overall Study
COMPLETED
|
50
|
45
|
54
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Count of times driving after combined cannabis use in the past 3 months
Baseline characteristics by cohort
| Measure |
Personalized Feedback
n=50 Participants
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 and Text Messages
n=45 Participants
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.
|
Information Only
n=54 Participants
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.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex/Gender, Customized
Male
|
11 Participants
n=14 Participants
|
14 Participants
n=36 Participants
|
14 Participants
n=324 Participants
|
39 Participants
n=49 Participants
|
|
Sex/Gender, Customized
Other selected
|
5 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
10 Participants
n=49 Participants
|
|
Age, Continuous
|
20.18 Years
STANDARD_DEVIATION 2.00 • n=14 Participants
|
21.07 Years
STANDARD_DEVIATION 3.22 • n=36 Participants
|
20.87 Years
STANDARD_DEVIATION 2.98 • n=324 Participants
|
20.70 Years
STANDARD_DEVIATION 2.78 • n=49 Participants
|
|
Sex/Gender, Customized
Female
|
33 Participants
n=14 Participants
|
30 Participants
n=36 Participants
|
37 Participants
n=324 Participants
|
100 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=14 Participants
|
35 Participants
n=36 Participants
|
45 Participants
n=324 Participants
|
120 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
5 Participants
n=14 Participants
|
5 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
12 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
10 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
2 Participants
n=49 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
5 Participants
n=49 Participants
|
|
Driving after cannabis use in the past 3 months
|
21.18 Driving events
STANDARD_DEVIATION 24.75 • n=14 Participants • Count of times driving after combined cannabis use in the past 3 months
|
28.93 Driving events
STANDARD_DEVIATION 28.76 • n=36 Participants • Count of times driving after combined cannabis use in the past 3 months
|
25.31 Driving events
STANDARD_DEVIATION 28.18 • n=324 Participants • Count of times driving after combined cannabis use in the past 3 months
|
25.02 Driving events
STANDARD_DEVIATION 27.25 • n=49 Participants • Count of times driving after combined cannabis use in the past 3 months
|
|
Driving after combined alcohol and cannabis use in the past 3 months
|
3.46 Driving events
STANDARD_DEVIATION 13.19 • n=14 Participants
|
8.73 Driving events
STANDARD_DEVIATION 21.38 • n=36 Participants
|
5.48 Driving events
STANDARD_DEVIATION 15.96 • n=324 Participants
|
5.76 Driving events
STANDARD_DEVIATION 16.97 • n=49 Participants
|
PRIMARY outcome
Timeframe: 3-month post-intervention follow-up assessmentPopulation: The participant flow includes all participants who completed the baseline survey and were randomized to 1 of 3 conditions. The 3-month timepoint reported here includes only participants who completed the baseline survey and 3-month follow-up survey. The 3-month follow-up survey was completed 3 months after completing the baseline intervention.
Self-reported count of driving-after-cannabis-use episodes during the prior 3 months, assessed at the 3-month post-intervention follow-up.
Outcome measures
| Measure |
Personalized Feedback
n=45 Participants
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 and Text Messages
n=38 Participants
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.
|
Information Only
n=48 Participants
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.
|
|---|---|---|---|
|
Driving After Cannabis Use
|
13.86 Driving events
Standard Deviation 19.90
|
14.72 Driving events
Standard Deviation 21.78
|
20.15 Driving events
Standard Deviation 27.79
|
PRIMARY outcome
Timeframe: 6 months post-intervention follow-up assessmentPopulation: The participant flow includes all participants who completed the baseline survey and were randomized to 1 of 3 conditions. The 6-month timepoint reported here includes only participants who completed the baseline survey and 6-month follow-up survey.
Self-reported number of times participants drove after cannabis use during the prior 3 months, assessed at the 6-month post-intervention follow-up.
Outcome measures
| Measure |
Personalized Feedback
n=41 Participants
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 and Text Messages
n=38 Participants
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.
|
Information Only
n=42 Participants
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.
|
|---|---|---|---|
|
Driving After Cannabis Use
|
8.40 Driving events
Standard Deviation 15.73
|
17.45 Driving events
Standard Deviation 25.26
|
17.23 Driving events
Standard Deviation 23.22
|
SECONDARY outcome
Timeframe: 3-month post-intervention follow-up assessmentSelf-reported number of times participants drove after combined alcohol and cannabis use during the prior 3 months, assessed at the 3-month post-intervention follow-up.
Outcome measures
| Measure |
Personalized Feedback
n=45 Participants
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 and Text Messages
n=38 Participants
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.
|
Information Only
n=48 Participants
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.
|
|---|---|---|---|
|
Driving After Combined Alcohol and Cannabis Use
|
1.16 Driving events
Standard Deviation 3.15
|
2.05 Driving events
Standard Deviation 7.57
|
0.80 Driving events
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: 6 months post-intervention follow-up assessmentSelf-reported number of times participants drove after combined alcohol and cannabis use during the prior 3 months, assessed at the 6-month post-intervention follow-up.
Outcome measures
| Measure |
Personalized Feedback
n=41 Participants
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 and Text Messages
n=38 Participants
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.
|
Information Only
n=42 Participants
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.
|
|---|---|---|---|
|
Driving After Combined Alcohol and Cannabis Use
|
0.36 Driving events
Standard Deviation 1.04
|
1.24 Driving events
Standard Deviation 3.49
|
3.44 Driving events
Standard Deviation 10.66
|
Adverse Events
Personalized Feedback
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Personalized Feedback and Text Messages
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Information Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place