Clinical trial NCT06891235: Study of Oral Fluid Testing Approach
Official title: Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cannabis Use
Cannabis Intoxication
Cannabis Use Disorder
Keywords: cannabis use
young adult
oral fluid testing
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample recruited from the Greater Boston area

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 18-30 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 and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~Day 3; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~Day 12; TLFB interview, urine test, oral fluid test, survey, interview).


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 (2-3 weeks).
* To proceed to oral fluid testing, positive result for urinary TCH-COOH

Exclusion Criteria:

• Inability/unwillingness to provide contact information

Primary outcomes:
measure: Testing duration: self-testing
timeFrame: Across 6 days leading up to the Day-12 visit
measure: Testing duration: observed test
timeFrame: Day of/During the Day-12 visit
measure: Oral fluid testing protocol adherence: self-testing completed
timeFrame: Across 6 days leading up to the Day-12 visit
measure: Oral fluid testing protocol adherence: observed test completed
timeFrame: Day of/During the Day-12 visit
measure: Oral fluid testing protocol adherence: testing steps performed
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
measure: Oral fluid testing protocol adherence: testing steps performed correctly
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
measure: Unreadable test results
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
measure: Inconclusive test results
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
measure: Oral fluid test results
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
measure: Oral fluid acceptability
timeFrame: Day-12 visit
measure: Use/Non-use intervals of 4 days
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
measure: Use/Non-use
timeFrame: Day-12 visit
Secondary outcomes:
measure: Use/Non-use for intervals of 2-8 days
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
Other outcomes:
measure: Within-day frequency of cannabis use
timeFrame: Day-12 visit
measure: Timing of cannabis use
timeFrame: Across 6 days leading up to the Day-12 visit; Day of/During the Day-12 visit
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: