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Recruiting NCT06891235

Study of an Oral Fluid Testing Approach

— Observational Cannabis Use Cannabis Intoxication Cannabis Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biologic testing for THC.
Who it may be relevant to
Registry conditions: Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials

Overview

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).

Interventions

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

Primary outcome measures

  • Testing duration: self-testing [Time frame: Across 6 days leading up to the Day-21 visit]
  • Testing duration: observed test [Time frame: Day of/During the Day-21 visit]
  • Oral fluid testing protocol adherence: self-testing completed [Time frame: Across 6 days leading up to the Day-21 visit]
  • Oral fluid testing protocol adherence: observed test completed [Time frame: Day of/During the Day-21 visit]
  • Oral fluid testing protocol adherence: testing steps performed [Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit]
  • Oral fluid testing protocol adherence: testing steps performed correctly [Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit]
  • Unreadable test results [Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit]
  • Inconclusive test results [Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit]
  • Oral fluid test results [Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit]
  • Oral fluid acceptability [Time frame: Day-21 visit]
Secondary outcome measures (1)
  • Use/Non-use for intervals of 2-8 days [Time frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit]

Eligibility criteria

Inclusion criteria

  • Age 18 to 30 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Identifiers

NCT: NCT06891235 · IRB-P00050265

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗