Study of Oral Fluid Testing Approach (SOFTA)

Oral Fluid Testing to Assess Cannabis Non-Use in Remote Clinical Trials

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).

Study Overview

• Status: Recruiting
• Conditions: Cannabis Use; Cannabis Use Disorder; Cannabis Intoxication
• Intervention / Treatment: Other: Biologic testing for THC

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sion K Harris, PhD, RN; Phone Number: 857-218-4304; Email: sion.harris@childrens.harvard.edu
• Study Contact Backup: Name: Lydia A Shrier, MD, MPH; Phone Number: (617) 355-8306; Email: lydia.shrier@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Lydia A. Shrier, MD, MPH; Phone Number: 617-355-8306; Email: lydia.shrier@childrens.harvard.edu
      • Principal Investigator: Lydia A. Shrier, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Participants will be asked to complete at-home urine test(s) and a series of oral fluid tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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 Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: young adult; cannabis use; oral fluid testing
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Marijuana Abuse; Organic Chemicals; Hydrocarbons; Terpenes; Cannabinoids; Dronabinol
• Other Study ID Numbers: IRB-P00050265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified survey data and biologic test result data
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No