Study of Oral Fluid Testing Approach

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06891235
Status
Recruiting

Conditions

  • Cannabis Intoxication
  • Cannabis Use
  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Biologic testing for THC — OTHER
    Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.

Study Details

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).

Key Dates

Start date
Oct 27, 2025
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Prospective community sample
    Community sample of 200 younger adults aged 18-30 years who have used cannabis in the past 30 days, report use frequency of ≥1x/week, and have a positive test for urinary 11-nor-9-carboxy-delta-9-tetrocannabinol (THC-COOH) at baseline

Primary Outcome Measure

Testing duration: self-testing [ Time Frame: Across 6 days leading up to the Day-21 visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Lydia A. Shrier, MD, MPH
617-355-8306
Lydia A. Shrier, MD, MPH (PRINCIPAL_INVESTIGATOR)

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