Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Boston Children's Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Testing duration: observed test
Study Overview
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 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).
Individuals age 18-30 are invited to screen here: https://redcap.link/softa-bch
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Individuals age 18-30 are invited to screen here: https://redcap.link/softa-bch
Arms & Interventions
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
Intervention: Biologic testing for THC (Other)
Outcomes
Primary Outcomes
Testing duration: observed test
Time Frame: Day of/During the Day-21 visit
Duration in minutes of observed self-testing during study visit
Testing duration: self-testing
Time Frame: Across 6 days leading up to the Day-21 visit
Duration in minutes of videos of self-testing
Oral fluid testing protocol adherence: self-testing completed
Time Frame: Across 6 days leading up to the Day-21 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-21 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-21 visit; Day of/During the Day-21 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-21 visit; Day of/During the Day-21 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-21 visit; Day of/During the Day-21 visit
Number and percent of oral fluid tests with unreadable results
Inconclusive test results
Time Frame: Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 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-21 visit; Day of/During the Day-21 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-21 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-21 visit; Day of/During the Day-21 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-21 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
Secondary Outcomes
- Use/Non-use for intervals of 2-8 days(Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit)
Investigators
Lydia Shrier
Research Director
Boston Children's Hospital