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Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials (SOFTA)
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).
Details
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Status | RECRUITING |
| Enrolment | 200 |
| Start date | 2025-10-27 |
| Completion | 2027-05 |
Conditions
- Cannabis Use
- Cannabis Intoxication
- Cannabis Use Disorder
Interventions
- Biologic testing for THC
Primary outcomes
- Testing duration: self-testing — Across 6 days leading up to the Day-21 visit
Duration in minutes of videos of self-testing - Testing duration: observed test — 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 — 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 — Day of/During the Day-21 visit
Number and percent of live self-testing completed - Oral fluid testing protocol adherence: testing steps performed — 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 — 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)
Countries
United States