Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic testing for THC | Other | Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Testing duration: self-testing | Duration in minutes of videos of self-testing | Across 6 days leading up to the Day-21 visit |
| Testing duration: observed test | Duration in minutes of observed self-testing during study visit | Day of/During the Day-21 visit |
| Oral fluid testing protocol adherence: self-testing completed | Number and percent of videos of self-testing completed | Across 6 days leading up to the Day-21 visit |
| Oral fluid testing protocol adherence: observed test completed | Number and percent of live self-testing completed | Day of/During the Day-21 visit |
| Oral fluid testing protocol adherence: testing steps performed | Number and percent of each step of self-testing performed (yes/no) | 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 | Number and percent of each step of self-testing performed correctly (yes/no) | Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |
| Unreadable test results | Number and percent of oral fluid tests with unreadable results | Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Use/Non-use for intervals of 2-8 days | 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 | Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Within-day frequency of cannabis use | Number of times cannabis used within each day included in the intervals being examined for agreement (Specific Aim 2A and 2B), reported on TLFB calendar interview | Day-21 visit |
| Timing of cannabis use |
Inclusion Criteria:
Exclusion Criteria:
• Inability/unwillingness to provide contact information
Not provided
Not provided
Community sample
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lydia A Shrier, MD, MPH | Contact | (617) 355-8306 | lydia.shrier@childrens.harvard.edu | |
| Madison M O'Connell, MPH | Contact | 617-919-6964 | softa@childrens.harvard.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
De-identified survey data and biologic test result data
De-identified scientific data will be shared as soon as possible. De-identified scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the award. The study data will be stored in the repository for at least 5 years.
De-identified scientific data and metadata arising from the project will be archived in the openICPSR repository. De-identified scientific data from this project will be findable through summary information (metadata) that will be readily available on the Center for Adolescent Behavioral Health Research website, the repository website, and clinicaltrials.gov.
Not provided
Not provided
| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
| Inconclusive test results | Number and percent of oral fluid tests with inconclusive results | Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |
| Oral fluid test results | Oral fluid test results for delta-9- tetrahydrocannabinol (delta-9-THC) on day of test (negative = non-use / positive = use) | Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |
| Oral fluid acceptability | 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 | Day-21 visit |
| Use/Non-use intervals of 4 days | 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) | Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |
| Use/Non-use | 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 | Day-21 visit |
Number of hours between last use and oral fluid testing time
| Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit |