Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Exploratory: Daily Follow-Up Messages |
Brief self-report from participants on anxiety, cannabis use, and sleep in the past 24 hours. |
One survey per day for 30 days (at the start of the 4 week study) |
|
Other |
Exploratory: Monthly Follow-Up Surveys |
Self-report from participants on anxiety, drug use, sleep, subjective cognitive functioning, and mental health. |
One survey per month for 5 months (at the end of the 4 week study) |
|
Primary |
Change in Anxiety/Negative Affect: Depression Anxiety Stress Scale (DASS21). |
The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Subjects are asked to use 4-point severity/frequency scales (higher values indicate greater severity) to rate the extent to which they have experienced each state. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items. Changes in DASS self-report will be tested in relation to THC and CBD blood levels. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration) |
|
Primary |
Change in Inflammation: Circulating Levels of cytokines (panel of inflammatory markers). |
Change in inflammation from before to after cannabis use will be tested in relation to THC and CBD blood levels. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration) |
|
Primary |
Patient Global Impression of Change: Global Impression of Change Scale (PGIC). |
Patient Global Impression of Change Scale (PGIC) measures self-reported change on a 1-7 scale (i.e. from 1 (very much worse) to 7 (very much improved)) in anxiety. Changes in this measure will be tested in relation to THC and CBD blood levels. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration) |
|
Secondary |
Cognitive Impairment: NIH Toolbox Cognitive Battery, Flanker Inhibitory Control Attention Task (FICA), International Shopping List Test (ISLT), and Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). |
Co-outcomes testing multiple domains of thinking, memory, and perception (NIH Toolbox), cognitive impairment in the domains of immediate and delayed recall (ISLT), attention and inhibitory control (FICA), and a subjective report of cognitive complaint (FACT-Cog). Cognitive outcomes are measured in standard scores (e.g. Range of >70 to >140 (Mean of 100 and SD of 15) with higher scores indicating better performance) and can be averaged to reflect a Standard score of overall cognitive function. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration) |
|
Secondary |
Stress reactivity induction |
Measure affective and stress reactivity responses through lab paradigm assessing attention to affective/stress inducing cues. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration). |
|
Secondary |
Depression and Mood |
Self-report of depression and mood states will be assessed at baseline and the four-week appointment. Given the observational nature of the study, co-outcomes are appropriate to comprehensively assess change in depression/negative affect over the course of the study. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration) |
|
Secondary |
Health and Wellbeing |
Self-report measure across primary domains of health-related well-being, diet, and assessment of sleep quality. |
Change over three time points over 4 weeks: Baseline (before 4 weeks of cannabis use), Pre-Administration (after 4 weeks of use, but before acute self-administration), and Post-Administration (after 4 weeks of use and after acute self-administration) |
|
Secondary |
Motor Battery: Balance and Motor Function |
Motor control assessed via dynamic sway, proprioception, and finger tapping rate. Motor outcomes can be aggregated via Z-score to reflect a Z-score of overall motor function. |
Change over three time points over 4 weeks. |
|
Secondary |
Objective physical activity/exercise |
Physical activity via objective daily data on wearable watch. |
Change over 2 weeks. |
|
Secondary |
Physical activity/exercise |
Physical activity via subjective self-report data. |
Change over 4 weeks. |
|