Study of Oral Fluid Testing Approach

NCT ID: NCT06891235

Last Updated: 2025-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-27

Study Completion Date

2027-05-31

Brief Summary

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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 and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~Day 3; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~Day 12; TLFB interview, urine test, oral fluid test, survey, interview).

Detailed Description

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Conditions

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Cannabis Use Cannabis Intoxication Cannabis Use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Biologic testing for THC

Intervention Type OTHER

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

Interventions

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Biologic testing for THC

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

Intervention Type OTHER

Eligibility Criteria

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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 (2-3 weeks).
* To proceed to oral fluid testing, positive result for urinary TCH-COOH

Exclusion Criteria

• Inability/unwillingness to provide contact information
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lydia Shrier

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lydia A Shrier, MD, MPH

Role: CONTACT

(617) 355-8306

Sion K Harris, PhD, RN

Role: CONTACT

857-218-4304

Facility Contacts

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Lydia A. Shrier, MD, MPH

Role: primary

617-355-8306

Other Identifiers

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IRB-P00050265

Identifier Type: -

Identifier Source: org_study_id

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