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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials
- ClinicalTrials.gov ID
- NCT06891235
- Acronym / sponsor ID
- SOFTA / IRB-P00050265
- Conditions
- Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder
- Keywords
- cannabis use, young adult, oral fluid testing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective community sample | – | Other: Biologic testing for THCCommunity 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (2 listed)
- Inability/unwillingness to provide contact information
- Individuals age 18-35 are invited to screen here: https://redcap.link/softa-bch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic testing for THCParticipants will be asked to complete at-home urine test(s) and a series of oral fluid tests. | Other | Prospective community sample |
Primary outcome
Testing duration: self-testing
Time frame: Across 6 days leading up to the Day-28 visit
Duration in minutes of videos of self-testing
Testing duration: observed test
Time frame: Day of/During the Day-28 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-28 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-28 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-28 visit; Day of/During the Day-28 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-28 visit; Day of/During the Day-28 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-28 visit; Day of/During the Day-28 visit
Number and percent of oral fluid tests with unreadable results
Inconclusive test results
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 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-28 visit; Day of/During the Day-28 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-28 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-28 visit; Day of/During the Day-28 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-28 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
1 secondary outcome
Use/Non-use for intervals of 2-8 days
Time frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified survey data and biologic test result data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lydia A. Shrier, MD, MPH principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cannabis Use and Cannabis Intoxication, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Foday Nabbie (617-355-2525, softa@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Testing duration: self-testing (time frame: Across 6 days leading up to the Day-28 visit). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.