Study of an Oral Fluid Testing Approach (SOFTA)

June 27, 2026 updated by: Lydia Shrier, Boston Children's Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
        • Principal Investigator:
          • Lydia A. Shrier, MD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Testing duration: self-testing
Time Frame: Across 6 days leading up to the Day-21 visit
Duration in minutes of videos of self-testing
Across 6 days leading up to the Day-21 visit
Testing duration: observed test
Time Frame: Day of/During the Day-21 visit
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
Time Frame: Across 6 days leading up to the Day-21 visit
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
Time Frame: Day of/During the Day-21 visit
Number and percent of live self-testing completed
Day of/During the Day-21 visit
Oral fluid testing protocol adherence: testing steps performed
Time Frame: 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)
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
Time Frame: 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)
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Unreadable test results
Time Frame: 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
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Inconclusive test results
Time Frame: 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
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Oral fluid test results
Time Frame: 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)
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Oral fluid acceptability
Time Frame: 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
Day-21 visit
Use/Non-use intervals of 4 days
Time Frame: 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)
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit
Use/Non-use
Time Frame: 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
Day-21 visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use/Non-use for intervals of 2-8 days
Time Frame: 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
Across 6 days leading up to the Day-21 visit; Day of/During the Day-21 visit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Within-day frequency of cannabis use
Time Frame: Day-21 visit
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
Time Frame: Across 6 days leading up to the Day-21 visit; Day of/During the 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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