Cannabis UseSOFTANCT06891235
Study of an Oral Fluid Testing Approach
An observational study of Cannabis Use and Cannabis Intoxication, run by Boston Children's Hospital at 1 site in United States.
Trial 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 18-35 years who have used cannabis at least 1 time per week on… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder
- What is being tested?
- Biologic testing for THC
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to May 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Study population: Community sample
Who may be able to join
- Age 18 to 35 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
Who cannot join
- Inability/unwillingness to provide contact information
- Individuals age 18-35 are invited to screen here: https://redcap.link/softa-bch
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Lydia A. Shrier, MD, MPH, 617-355-8306, lydia.shrier@childrens.harvard.edu
Lydia A. Shrier, MD, MPH
About this study
Official title: Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials
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 18-35 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 28; TLFB interview, urine test, oral fluid test, survey, interview).
Individuals age 18-35 are invited to screen here: https://redcap.link/softa-bch
- Conditions
- Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder
- Being tested
- Biologic testing for THC
- Keywords
- cannabis use, young adult, oral fluid testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic testing for THCOther
Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.
| Study group | Role | What they receive |
|---|---|---|
| Prospective community sample | Community sample of 200 younger adults aged 18-35 years who have used cannabis in the past 30 days at baseline, report use frequency of ≥1x/week at baseline, and have a positive test for urinary 11-nor-9-carboxy-delta-9-tetrocannabinol (THC-COOH) at the Day-7 visit Receives: Other: Biologic testing for THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Testing duration: self-testing
Duration in minutes of videos of self-testing
Measured: Across 6 days leading up to the Day-28 visit
Testing duration: observed test
Duration in minutes of observed self-testing during study visit
Measured: Day of/During the Day-28 visit
Oral fluid testing protocol adherence: self-testing completed
Number and percent of videos of self-testing completed
Measured: Across 6 days leading up to the Day-28 visit
Oral fluid testing protocol adherence: observed test completed
Number and percent of live self-testing completed
Measured: Day of/During the Day-28 visit
Oral fluid testing protocol adherence: testing steps performed
Number and percent of each step of self-testing performed (yes/no)
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Oral fluid testing protocol adherence: testing steps performed correctly
Number and percent of each step of self-testing performed correctly (yes/no)
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Unreadable test results
Number and percent of oral fluid tests with unreadable results
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Inconclusive test results
Number and percent of oral fluid tests with inconclusive results
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Oral fluid test results
Oral fluid test results for delta-9- tetrahydrocannabinol (delta-9-THC) on day of test (negative = non-use / positive = use)
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Oral fluid acceptability
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
Measured: Day-28 visit
Use/Non-use intervals of 4 days
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)
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Use/Non-use
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
Measured: Day-28 visit
Secondary outcomes (1)
Use/Non-use for intervals of 2-8 days
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
Measured: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start27 Oct 2025
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lydia Shrier, Boston Children's Hospital
- Investigators
- Lydia A. Shrier, MD, MPH, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891235
- Sponsor's protocol ID
- IRB-P00050265
- Acronym
- SOFTA
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified survey data and biologic test result data