Pain Inflammation and Cannabis in HIV

Change in self-reported Pain Severity was measured at weekly intervals from baseline through 14 weeks using the Brief Pain Inventory (BPI) pain severity subscale. The BPI Pain Severity subscale uses a 0-10 numerical rating scale where 0 = "No pain at all" and 10 = "Pain as bad as you can imagine; completely interferes" such that higher scores were associated with increased Pain Severity. Participants were asked to assign a score to their pain, on average, over the prior week. Scores were summarized by study arm. For purposes of this study change in Pain Severity scores from baseline to 14 weeks following intervention were summarized and reported with positive values being indicative of increased pain severity compared to baseline and negative values being indicative of decreased pain severity compared to baseline.

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-10 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-10 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-4 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-4 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for TNFa are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of TNFa from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-6 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-6 from baseline to 14 weeks following intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.

Change in Antiretroviral medication adherence from baseline to 14 weeks was assessed using the Visual Analog Scale (VAS) of antiretroviral therapy (ART) adherence. This is an ordinal scale representing the percentage of medication taken to that which had been administered. Participants were presented with a visual ranging from 0% to 100% scaled at 10% increments and asked to provide a best guess as to how much medicine was taken over the prior 30 days with 0% signifying no medication, 50% signifying half of administered medication taken, and 100% signifying that every single dose of medication was taken. Higher scores were indicative of increased medication adherence. Scores were summarized by study arm. For purposes of this study change in antiretroviral adherence score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased medication adherence from baseline and negative values are indicative of decreased adherence.

Change in HIV viral load suppression from baseline was measured and assessed at 14 weeks. Blood draws were obtained at baseline and 14 weeks following intervention and samples were processed, analyzed, and quantified using the Abbott RealTime HIV-1 Viral Load assay. Results were summarized and HIV viral load values were reported in copies/milliliter (copies/mL). For purposes of this study change in HIV viral load from baseline to 14 weeks following intervention were summarized and reported. Positive values are indicative of increased HIV viral load levels compared to baseline and negative values are indicative of decreased/suppressed HIV viral load levels compared to baseline. A high HIV viral load in the blood is associated with increased risk of disease progression and HIV transmission.

Change in Depression score was measured at baseline and 14 weeks using the Center for Epidemiologic Studies Depression (CES-D) questionnaire. The CES-D questionnaire is a 20-item screening tool used to assess the severity and frequency of depressive symptoms. Participants were asked to rate each of the 20 items using a 4-point Likert scale ranging from 0 ("Rarely/none of the time") to 3 ("Most/all of the time") to describe symptoms over the prior week (Questions, 4, 8, 12, and 16 were reverse-scored). Scores were summed to yield an overall possible scoring range of 0-60 with higher scores being indicative of increased severity/frequency of depressive symptoms. For purposes of this study change in depression score from baseline to 14 weeks following intervention was summarized. Positive values are indicative of increased depressive symptom severity/frequency compared to baseline and negative values are indicative of decreased depressive symptom severity/frequency compared to baseline.

Change in Anxiety score was measured and assessed at baseline and 14 weeks using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item screening tool used to assess the severity of anxiety-related symptoms. Participants were asked to rate each of the 7 items using a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day") to indicate how long they have been bothered by the problems listed over the prior 2-week period, yielding an overall possible score of 0-21, with higher scores being indicative of worsening anxiety. Scores were summarized by study arm. For purposes of this study change in anxiety score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased anxiety symptoms compared to baseline and negative values are indicative of decreased anxiety symptoms compared to baseline.