Study of an Oral Fluid Testing Approach
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-30
SponsorBoston Children's Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Community sample
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biologic testing for THC
Other interventionParticipants will be asked to complete at-home urine test(s) and a series of oral fluid tests.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Prospective community sample1 intervention
Trial outcomes
Primary outcomes
1
Testing duration: self-testing
Duration in minutes of videos of self-testing
Time frame
Across 6 days leading up to the Day-21 visit2
Testing duration: observed test
Duration in minutes of observed self-testing during study visit
Time frame
Day of/During the Day-21 visit3
Oral fluid testing protocol adherence: self-testing completed
Number and percent of videos of self-testing completed
Time frame
Across 6 days leading up to the Day-21 visit4
Oral fluid testing protocol adherence: observed test completed
Number and percent of live self-testing completed
Time frame
Day of/During the Day-21 visitSecondary outcomes
1
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
Time frame
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visitOther outcomes
1
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
Time frame
Day-21 visit2
Timing of cannabis use
Number of hours between last use and oral fluid testing time
Time frame
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston Children's Hospital
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov