Clinical Trial

Study of an Oral Fluid Testing Approach

Study acronym: SOFTA
Recruiting
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Summary
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-03-17; most recent amendment 2026-06-27.
Status change: Not Yet Recruiting → Recruiting 2025-10-29
Trial Details
NCT Number NCT06891235
Lead Sponsor Boston Children's Hospital
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder
Enrollment 200 participants
Start Date 2025-10-27
Primary Completion 2027-02 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-01