Study of Oral Fluid Testing Approach

NCT06891235 | Recruiting

• 1 other identifier: IRB-P00050265
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Cannabis Use Disorder; Cannabis Use; Cannabis Intoxication

Keywords

cannabis use; young adult; oral fluid testing

Outcome Measures

Primary Outcomes (12)

• 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

• 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

Secondary Outcomes (1)

• 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

Other Outcomes (2)

• Within-day frequency of cannabis use

  Day-21 visit

• Timing of cannabis use

  Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit

Study Arms (1)

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

Other: Biologic testing for THC

Interventions

Biologic testing for THC OTHER

Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.

Prospective community sample

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• Inability/unwillingness to provide contact information

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lydia A Shrier, MD, MPH

CONTACT

(617) 355-8306; lydia.shrier@childrens.harvard.edu

Sion K Harris, PhD, RN

CONTACT

857-218-4304; sion.harris@childrens.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 24, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)