An Observational Study of the Effects of Edible Cannabis and Its Constituent Cannabinoids on Pain, Inflammation, and Cognition

Time frame

Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration) using the total RMDQ score (0-24).

Measure

MEAN · score on a scale

Reporting status

POSTED

The Roland Morris Disability Questionnaire assesses self-rated physical disability caused by low back pain. Scores range from 0 to 24, with higher scores indicating more pain interference.

Time frame

Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use) and Pre-Administration (after 2 weeks of use and before acute administration).

Measure

MEAN · pg/mL

Reporting status

POSTED

Tests levels of recent inflammation (panel of inflammatory markers) before and after cannabis use. Higher numbers indicate higher levels of circulating pro-inflammatory cytokines. Results are in pg/mL and are separated by the three cytokines: IL-1b, IL-6, and IL-10.

Time frame

Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).

Measure

MEAN · score on a scale

Reporting status

POSTED

Co-outcomes testing cognitive impairment in the domains of immediate and delayed recall (ISLT) and attention and inhibitory control (FICA). 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.

Time frame

Change over two time points over 2 weeks: Baseline (before 2 weeks of edible use), Pre-Administration (after 2 weeks of use and before acute administration).

Measure

MEAN · score on a scale

Reporting status

POSTED

Subjective report of cognitive function using the Perceived Cognitive Impairments subscale of the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Possible scores range from 0-80 where higher scores are associated with higher levels of perceived impairment.

Time frame

Change over 2 weeks

Measure

MEAN · score on a scale

Reporting status

POSTED

Test effects of cannabinoids on pain using the NIH Pain intensity scale for "current pain" (on a scale from 0-10 with 10 being the worst).

Time frame

Change over 2 weeks

Measure

MEAN · units on a scale

Reporting status

POSTED

Self-report measure across primary domains of diet, assessment of sleep quality, and health-related well-being. Each domain was assessed with the following single items: Diet: "In general, how healthy is your overall diet? Would you say" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor) Sleep Quality: "During the past 2 weeks, how would you rate your sleep quality overall?" (response options 0- very good; 1- fairly good; 2- fairly bad; 3- very bad") Health Related Wellbeing: "In general, how would you describe your health?" (response options 0- excellent; 1- very good; 2- good; 3- fair; 4- poor)

Time frame

Change over 4 weeks

Measure

MEAN · score on a scale

Reporting status

POSTED

The Pittsburgh Sleep Quality Assessment (PSQI) is a self-report assessment of sleep quality.9 self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores for each question range from 0 to 3, with higher scores indicating more acute sleep disturbances (Scores range from 0 to 21 overall, with scores greater than 5 suggesting significant sleep difficulties).

Time frame

Change over 2 weeks

Measure

MEAN · z-score

Reporting status

POSTED

Motor control assessed via dynamic sway and proprioception. Motor outcomes were aggregated to reflect a Z-score of overall motor function. Scores reported below are sum of Motor Battery Balance z-scores (Eyes Open, Eyes Closed, and Head Back). Higher scores correspond to worse balance- there is not a maximum score.

Time frame

Change over 2 weeks

Measure

MEAN · score on a scale

Reporting status

POSTED

The DASS21 is a 21-item scale that measures self-reported change in anxiety, depression, and stress symptoms. Participants 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. For this aim, the Depression and Stress subscales were used. Depression subscale score range 0-21 Normal (0 to 4), Mild (5 to 6), Moderate, (7 to 10), Severe (11 to 13), Extremely Severe (14 and above) Stress subscale score range 0-33 Normal (0 to 14), Mild (15 to 18), Moderate, (19 to 25), Severe (26 to 33)

Time frame

2 Weeks

Measure

MEAN · standard score

Reporting status

POSTED

Co-outcomes testing cognitive impairment after acute use of cannabis in the domains of immediate and delayed recall (ISLT) and and attention and inhibitory control (FICA). 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.

Time frame

Change over 2 week primary exposure period.

Measure

MEAN · score on a scale

Reporting status

POSTED

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 pain. Changes in this measure will be tested in relation to THC and CBD blood levels. Scale possible score range 1-7, with higher scores indicating the largest amount of possible change. Importantly, it is a subjective self-assessment of change and is only measured at the 2 week timepoint.

Time frame

2 weeks (daily)

Measure

MEAN · units on a scale

Reporting status

POSTED

Brief self-report from participants on pain and sleep in the past 24 hours. These are 1-item novel questions in a daily, text based survey. Pain and sleep are on a scale of 1-10, with higher numbers being more pain or better sleep. Score is an average rating over 14 days.

Time frame

6 months (monthly)

Measure

MEAN · units on a scale

Reporting status

POSTED

Self-report from participants on pain levels (0-10 with 10 being worst pain), sleep quality (0-10 with 10 being best sleep), perceived cognitive ability (0 - 27 with 27 being the best), perceived cognitive impairments (0-72 with 72 being the worst), and general health (0-4 with 4 being best). Scores are reported as average scores reported once a month over six months.

Time frame

2 weeks

Measure

MEAN · minutes

Reporting status

POSTED

Physical activity via objective daily data on wearable watch as measured by average minutes of moderate to vigorous physical activity (MVPA).

Time frame

2 weeks

Measure

MEAN · score on a scale

Reporting status

POSTED

Physical activity via subjective self-report data using the Stanford Leisure-Time Activity Categorical item with 6 item responses (L-CAT; 1-6). Scores are reported as a mean between 1 and 6, larger numbers correspond to higher levels of activity.

Note: 268 participants were consented for the study. Among those, 253 submitted photos of their experimental product and were thus assigned to product groups. It is not possible to "group" the 15 participants lost to attrition at that point in the study flow.