Recruiting

Oral Fluid Testing

Sponsor:

Boston Children's Hospital

Code:

NCT06891235

Conditions

Cannabis Use

Cannabis Intoxication

Cannabis Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Biologic testing for THC

Study Details

Brief 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 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

Study ID

NCT06891235

Start date

Oct 27, 2025

Status verified date

Oct, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Inability/unwillingness to provide contact information

Individuals age 18-35 are invited to screen here: https://redcap.link/softa-bch

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Biologic testing for THC

Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.

Primary outcome measure

  • Testing duration: self-testing [ Time Frame: Across 6 days leading up to the Day-28 visit ]
  • Testing duration: observed test [ Time Frame: Day of/During the Day-28 visit ]
  • Oral fluid testing protocol adherence: self-testing completed [ Time Frame: Across 6 days leading up to the Day-28 visit ]
  • Oral fluid testing protocol adherence: observed test completed [ Time Frame: Day of/During the Day-28 visit ]
  • 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 ]
  • 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 ]
  • Unreadable test results [ Time Frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit ]
  • Inconclusive 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 [ Time Frame: Across 6 days leading up to the Day-28 visit; Day of/During the Day-28 visit ]
  • Oral fluid acceptability [ Time Frame: Day-28 visit ]
  • 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 ]
  • Use/Non-use [ Time Frame: Day-28 visit ]

Central Contacts and Locations

Central contacts

Foday Nabbie

617-355-2525softa@childrens.harvard.edu

Madison M O'Connell, MPH

617-919-6964madison.oconnell@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Lydia A. Shrier, MD, MPH

617-355-8306lydia.shrier@childrens.harvard.edu

Principal Investigator:

Lydia A. Shrier, MD, MPH

More Information

Sponsor

Boston Children's Hospital

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • cannabis use
  • young adult
  • oral fluid testing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.