Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Location contact
Lydia A. Shrier, MD, MPH
CONTACT
Lydia A. Shrier, MD, MPH
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06891235
Study of an Oral Fluid Testing Approach
The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits across ~3-4 weeks and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (~Day 7; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (~Day 21; TLFB interview, urine test, oral fluid test, survey, interview).
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–30 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age 18 to 30 years
- Cannabis use on >=1x/week in the past 30 days
- Ownership of a portable device that is capable of videoconference and videorecording (i.e., smartphone, tablet computer, or laptop computer)
- Ability to read and speak English
- Availability for duration of the study (3-4 weeks).
- To proceed to oral fluid testing, positive result for urinary TCH-COOH
Exclusion criteria
- Inability/unwillingness to provide contact information
Treatment and study plan
Biologic testing for THC
OtherParticipants will be asked to complete at-home urine test(s) and a series of oral fluid tests.
Primary outcomes
-
Testing duration: self-testing
Time frame: Across 6 days leading up to the Day-21 visit
Duration in minutes of videos of self-testing
-
Testing duration: observed test
Time frame: Day of/During the Day-21 visit
Duration in minutes of observed self-testing during study visit
-
Oral fluid testing protocol adherence: self-testing completed
Time frame: Across 6 days leading up to the Day-21 visit
Number and percent of videos of self-testing completed
-
Oral fluid testing protocol adherence: observed test completed
Time frame: Day of/During the Day-21 visit
Number and percent of live self-testing completed
-
Oral fluid testing protocol adherence: testing steps performed
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Number and percent of each step of self-testing performed (yes/no)
-
Oral fluid testing protocol adherence: testing steps performed correctly
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Number and percent of each step of self-testing performed correctly (yes/no)
-
Unreadable test results
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Number and percent of oral fluid tests with unreadable results
-
Inconclusive test results
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Number and percent of oral fluid tests with inconclusive results
-
Oral fluid test results
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Oral fluid test results for delta-9- tetrahydrocannabinol (delta-9-THC) on day of test (negative = non-use / positive = use)
-
Oral fluid acceptability
Time frame: Day-21 visit
Measure of acceptability (usability, likability, burden), 5 items, 5-point Likert-type scale (1, Strongly Disagree to 5, Strongly Agree), with higher score indicating greater acceptability.
Benchmark for scale: ≥80% of participants with mean item score ≥4 out of 5
-
Use/Non-use intervals of 4 days
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Agreement between oral fluid results for 3 consecutive days (any positive = use / all negative = non-use) and self-report on timeline follow-back (TLFB) calendar interview for the same 3 days plus 1 day earlier (any days of use = use / no days of use = non-use).
Benchmark: ≥ moderate agreement (Cohen's kappa ≥ 0.6)
-
Use/Non-use
Time frame: Day-21 visit
Agreement between oral fluid test results (positive/negative) and urine test result (positive/negative).
Benchmarks: strong agreement (Cohen's kappa ≥ 0.8) for use; weak agreement (Cohen's kappa < 0.6) for non-use
Secondary outcomes
-
Use/Non-use for intervals of 2-8 days
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Agreement (use/non-use) between oral fluid test results and cannabis use reported on TLFB calendar interview for corresponding intervals ranging from 2 days (day of and day before testing, ≤24 hours prior) to 8 days
Other outcomes
-
Within-day frequency of cannabis use
Time frame: Day-21 visit
Number of times cannabis used within each day included in the intervals being examined for agreement (Specific Aim 2A and 2B), reported on TLFB calendar interview
-
Timing of cannabis use
Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Number of hours between last use and oral fluid testing time
Study contacts
Contact information is provided by the study sponsor or research team.
Lydia A Shrier, MD, MPH
CONTACT
Madison M O'Connell, MPH
CONTACT
Sponsors and collaborators
Lead sponsor
Boston Children's Hospital
Other
Collaborators
- National Institute on Drug Abuse (NIDA)
Registry information
Official study title
Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials
Acronym: SOFTA
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 24, 2025
- Registry last updated
- Jul 1, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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