Trial Outcomes & Findings for Pain Inflammation and Cannabis in HIV (NCT NCT05554146)

Last Updated: 2025-11-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

At weekly intervals from Baseline to 14 weeks

Results posted on

2025-11-13

Participant Flow

Thirty-five (35) participants were consented and enrolled into the study. One participant completed screening, consent and enrollment, but then did not want to be randomized into one of the coupon categories (study arms). As such, 34 patients were randomized into the study.

Participant milestones

Participant milestones
Measure	Coupon for a Discounted Placebo Product Participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for Placebo Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted High Tetrahydrocannabinol (THC) Product Participants who were previously randomized to a coupon for discounted 4.3 mg tetrahydrocannabinol (THC)/0.7 mg cannabidiol (CBD) soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for High THC Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted Equal THC and Cannabidiol (CBD) Product Participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted High CBD Product Participants who were previously randomized to a coupon for discounted 0.2 mg THC/4.8 mg CBD soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for High CBD Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Overall Study STARTED	9	8	9	8
Overall Study COMPLETED	8	6	8	8
Overall Study NOT COMPLETED	1	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Coupon for a Discounted Placebo Product Participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for Placebo Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted High Tetrahydrocannabinol (THC) Product Participants who were previously randomized to a coupon for discounted 4.3 mg tetrahydrocannabinol (THC)/0.7 mg cannabidiol (CBD) soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for High THC Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted Equal THC and Cannabidiol (CBD) Product Participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Overall Study Adverse Event	0	1	0
Overall Study Protocol Violation	0	1	0
Overall Study No longer interested in participating	0	0	1
Overall Study Lost to Follow-up	1	0	0

Baseline Characteristics

Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Coupon for a Discounted Placebo Product n=9 Participants Participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for Placebo Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted High THC Product n=8 Participants Participants who were previously randomized to a coupon for discounted 4.3 mg THC/0.7 mg CBD soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for High THC Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted Equal THC and CBD Product n=9 Participants Participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Coupon for a Discounted High CBD Product n=8 Participants Participants who were previously randomized to a coupon for discounted 0.2 mg THC/4.8 mg CBD soft-gel capsules by the collaborators, Vireo, will be observed. Receipt of Coupon for High CBD Soft-Gel Capsule: The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study	Total n=34 Participants Total of all reporting groups
Age, Continuous	50.1 years STANDARD_DEVIATION 10.9 • n=9 Participants	52.5 years STANDARD_DEVIATION 9.65 • n=8 Participants	55.9 years STANDARD_DEVIATION 10.7 • n=9 Participants	61.8 years STANDARD_DEVIATION 6.96 • n=8 Participants	55.0 years STANDARD_DEVIATION 9.63 • n=34 Participants
Sex: Female, Male Female	0 Participants n=9 Participants	5 Participants n=8 Participants	7 Participants n=9 Participants	4 Participants n=8 Participants	16 Participants n=34 Participants
Sex: Female, Male Male	9 Participants n=9 Participants	3 Participants n=8 Participants	2 Participants n=9 Participants	4 Participants n=8 Participants	18 Participants n=34 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=9 Participants	1 Participants n=8 Participants	6 Participants n=9 Participants	4 Participants n=8 Participants	17 Participants n=34 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=9 Participants	7 Participants n=8 Participants	3 Participants n=9 Participants	4 Participants n=8 Participants	17 Participants n=34 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=34 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=9 Participants	1 Participants n=8 Participants	1 Participants n=34 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Black or African American	3 Participants n=9 Participants	6 Participants n=8 Participants	5 Participants n=9 Participants	4 Participants n=8 Participants	18 Participants n=34 Participants
Race (NIH/OMB) White	3 Participants n=9 Participants	1 Participants n=8 Participants	0 Participants n=9 Participants	1 Participants n=8 Participants	5 Participants n=34 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=9 Participants	0 Participants n=8 Participants	0 Participants n=34 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=9 Participants	1 Participants n=8 Participants	4 Participants n=9 Participants	2 Participants n=8 Participants	10 Participants n=34 Participants
Region of Enrollment United States	9 participants n=9 Participants	8 participants n=8 Participants	9 participants n=9 Participants	8 participants n=8 Participants	34 participants n=34 Participants
CD4 Count	658.63 cells/uL STANDARD_DEVIATION 414.89 • n=8 Participants • Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm.	699.12 cells/uL STANDARD_DEVIATION 185.88 • n=8 Participants • Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm.	828.78 cells/uL STANDARD_DEVIATION 444.96 • n=9 Participants • Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm.	621.43 cells/uL STANDARD_DEVIATION 458.37 • n=7 Participants • Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm.	708.47 cells/uL STANDARD_DEVIATION 375.61 • n=32 Participants • Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm.
Pain Severity Score	6.22 score on a scale STANDARD_DEVIATION 2.54 • n=9 Participants	7.63 score on a scale STANDARD_DEVIATION 1.18 • n=8 Participants	8.56 score on a scale STANDARD_DEVIATION 1.13 • n=9 Participants	7.5 score on a scale STANDARD_DEVIATION 1.85 • n=8 Participants	7.47 score on a scale STANDARD_DEVIATION 1.68 • n=34 Participants
Circulating levels of Pro-Inflammatory and Anti-inflammatory Cytokines Interleukin-10 (IL-10)	4.01 NPX value STANDARD_DEVIATION 0.53 • n=5 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	3.7 NPX value STANDARD_DEVIATION 0.3 • n=7 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	3.98 NPX value STANDARD_DEVIATION 0.68 • n=8 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	3.69 NPX value STANDARD_DEVIATION 0.35 • n=6 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	3.84 NPX value STANDARD_DEVIATION 0.47 • n=26 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.
Circulating levels of Pro-Inflammatory and Anti-inflammatory Cytokines Interleukin-4 (IL-4)	0.94 NPX value STANDARD_DEVIATION 0.77 • n=5 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	0.47 NPX value STANDARD_DEVIATION 0.25 • n=7 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	0.55 NPX value STANDARD_DEVIATION 0.49 • n=8 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	0.81 NPX value STANDARD_DEVIATION 1.22 • n=6 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	0.66 NPX value STANDARD_DEVIATION 0.65 • n=26 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.
Circulating levels of Pro-Inflammatory and Anti-inflammatory Cytokines Tumor Necrosis Factor Alpha (TNFa)	4.32 NPX value STANDARD_DEVIATION 0.89 • n=5 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	3.95 NPX value STANDARD_DEVIATION 0.31 • n=7 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	4.11 NPX value STANDARD_DEVIATION 0.49 • n=8 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	3.97 NPX value STANDARD_DEVIATION 0.24 • n=6 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	4.08 NPX value STANDARD_DEVIATION 0.46 • n=26 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.
Circulating levels of Pro-Inflammatory and Anti-inflammatory Cytokines Interleukin-6 (IL-6)	4.2 NPX value STANDARD_DEVIATION 0.73 • n=5 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	4.17 NPX value STANDARD_DEVIATION 1.11 • n=7 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	4.42 NPX value STANDARD_DEVIATION 0.67 • n=8 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	4.52 NPX value STANDARD_DEVIATION 1.19 • n=6 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.	4.33 NPX value STANDARD_DEVIATION 0.92 • n=26 Participants • Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the sample. Accordingly, no baseline results data are available for these patients.
Antiretroviral Medication Adherence Score	9.25 score on a scale STANDARD_DEVIATION 1.5 • n=4 Participants • A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No data from these participants was able to be collected/reported.	10 score on a scale STANDARD_DEVIATION 0 • n=4 Participants • A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No data from these participants was able to be collected/reported.	8 score on a scale STANDARD_DEVIATION 3.46 • n=3 Participants • A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No data from these participants was able to be collected/reported.	8.25 score on a scale STANDARD_DEVIATION 2.36 • n=4 Participants • A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No data from these participants was able to be collected/reported.	8.93 score on a scale STANDARD_DEVIATION 1.72 • n=15 Participants • A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No data from these participants was able to be collected/reported.
HIV Viral Load Suppression	9560.33 copies/mL STANDARD_DEVIATION 29836.6 • n=9 Participants	0 copies/mL STANDARD_DEVIATION 0 • n=8 Participants	4.67 copies/mL STANDARD_DEVIATION 13.2 • n=9 Participants	18193.38 copies/mL STANDARD_DEVIATION 5000.73 • n=8 Participants	6812.71 copies/mL STANDARD_DEVIATION 9078.06 • n=34 Participants
Depression Score	24.14 score on a scale STANDARD_DEVIATION 11.61 • n=7 Participants • 4 participants did not complete the Depression questionnaire during baseline visit. No data from these participants was able to be collected/reported.	23 score on a scale STANDARD_DEVIATION 9.93 • n=7 Participants • 4 participants did not complete the Depression questionnaire during baseline visit. No data from these participants was able to be collected/reported.	16.37 score on a scale STANDARD_DEVIATION 7.93 • n=8 Participants • 4 participants did not complete the Depression questionnaire during baseline visit. No data from these participants was able to be collected/reported.	17.88 score on a scale STANDARD_DEVIATION 11.19 • n=8 Participants • 4 participants did not complete the Depression questionnaire during baseline visit. No data from these participants was able to be collected/reported.	20.13 score on a scale STANDARD_DEVIATION 10.12 • n=30 Participants • 4 participants did not complete the Depression questionnaire during baseline visit. No data from these participants was able to be collected/reported.
Anxiety Score	12.43 score on a scale STANDARD_DEVIATION 6.85 • n=7 Participants • 4 participants did not complete the Anxiety questionnaire during baseline visit. No data from these participants was able to be collected/reported.	5.71 score on a scale STANDARD_DEVIATION 3.09 • n=7 Participants • 4 participants did not complete the Anxiety questionnaire during baseline visit. No data from these participants was able to be collected/reported.	9.62 score on a scale STANDARD_DEVIATION 6.14 • n=8 Participants • 4 participants did not complete the Anxiety questionnaire during baseline visit. No data from these participants was able to be collected/reported.	7.38 score on a scale STANDARD_DEVIATION 6.59 • n=8 Participants • 4 participants did not complete the Anxiety questionnaire during baseline visit. No data from these participants was able to be collected/reported.	8.77 score on a scale STANDARD_DEVIATION 5.71 • n=30 Participants • 4 participants did not complete the Anxiety questionnaire during baseline visit. No data from these participants was able to be collected/reported.

PRIMARY outcome

Timeframe: At weekly intervals from Baseline to 14 weeks

Population: Number of participants analyzed is summarized for each arm/group at each week in the table below. Reasons for variability in the number of participants analyzed is attributable to missed virtual visits or incomplete data collection during specific timepoints.