Cannabis Intoxication, Cannabis Use, Cannabis Use Disorder
Conditions
Keywords
cannabis use, young adult, oral fluid testing
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
Interventions
OTHERBiologic testing for THC
Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.
Sponsors
Boston Children's Hospital
National Institute on Drug Abuse (NIDA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Testing duration: self-testing | Across 6 days leading up to the Day-21 visit | Duration in minutes of videos of self-testing |
| Testing duration: observed test | Day of/During the Day-21 visit | Duration in minutes of observed self-testing during study visit |
| Oral fluid testing protocol adherence: self-testing completed | 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 | Day of/During the Day-21 visit | Number and percent of live self-testing completed |
| Oral fluid testing protocol adherence: testing steps performed | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Agreement (use/non-use) between oral fluid test results and cannabis use reported on TLFB calendar interview for corresponding intervals ranging from 2 days (day of and day before testing, ≤24 hours prior) to 8 days |
Countries
United States
Contacts
CONTACTFoday Nabbie
CONTACTMadison M O'Connell, MPH
PRINCIPAL_INVESTIGATORLydia A. Shrier, MD, MPH
Boston Children's Hospital
Outcome results
None listed