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

Boston Children'S Hospital, Boston MA

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT Younger adults aged 18-30 years are using cannabis frequently and experiencing the dysfunction and distress of cannabis use disorder (CUD) at unprecedented rates. Facing numerous barriers to treatment and lack of diverse representation in research, younger adults with CUD need expanded opportunities to access interventions and to participate in clinical trials. Remote implementation offers a promising means to addressing these critical gaps in care and research. However, valid remote procedures for biologic assessment of a key outcome, reduction in cannabis use days, have not been established. We propose an approach to assessing cannabis use and non-use remotely via oral fluid testing, which can be directly observed, is easily and quickly accomplished with minimal training, has a short detection window (≤24-72 hours after cannabis use) and is less prone to alteration or falsification vs. urine and other biologic specimens. Using our experience with studying cannabis use in younger adults, telehealth preferences, fully remote interventions, and collecting and testing biologic specimens, we propose to evaluate a community sample of 200 individuals aged 18-30 years with past- 30-day cannabis use ≥1x/week. Participants will videorecord of daily oral fluid delta-9-tetrahydrocannabinol (delta-9-THC) testing on 6 consecutive days and live observed testing on the 7th day. We will assess completion of daily oral fluid testing and its performance in identifying cannabis use/non-use intervals, vs. self-report on timeline follow-back calendar interview. To do so, we will analyze performance of oral fluid test results over each period of 3 consecutive days, corresponding to a cannabis use/non-use interval of 4 days, which, based on our research, is a meaningful period of non-use following treatment in individuals who use cannabis frequently (5 possible 3-day testing intervals/participant, resulting in ≤1,000 intervals). We will also contrast oral fluid results with urine results to demonstrate the relative utility of oral fluid testing for establishing use/non-use over short intervals. The specific aims are 1) to establish the feasibility of remote testing for oral fluid delta-9-THC using video recordings on a personal device and live observation via videoconference call. We will used a mixed methods approach, including staff observation, participant survey, and participant interview to evaluate implementation, completion, acceptability, burden, and technical aspects of the oral fluid testing procedures; 2A) to determine agreement between oral fluid test results over 3 consecutive days (any positive = use, all negative = non-use) and self-reported cannabis use/non-use over the corresponding days on TLFB (4 days, 3 plus 1 day earlier); and 2B) to demonstrate agreement between results on a single oral fluid test and a single urine test obtained contemporaneously in individuals who have used cannabis ≥1x/week in the past 30 days. Identifying an approach to biologic assessment of cannabis non-use days that can be accomplished under video observation will substantially add to the rigor of remote clinical trials for CUD. Younger adults will particularly benefit from the enhanced evidence on remote interventions for CUD.