Study of Oral Fluid Testing Approach (SOFTA)

Boston Children's Hospital

Status: Enrolling

Conditions: Cannabis Use Disorder; Cannabis Intoxication; Cannabis Use

Treatments: Other: Biologic testing for THC

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06891235

IRB-P00050265

Details and patient eligibility

About

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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Prospective community sample

Description:

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

Treatment:

Other: Biologic testing for THC