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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA053997 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Colorado, Boulder | OTHER |
| University of Pittsburgh | OTHER |
| Vireo Health |
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This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. The investigators will observe how varying ratios of tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.
This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. The investigators will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary). The investigators will observe how pain and inflammation change in participants after they are randomized to receive high THC:low CBD product, an equal THC:CBD product, a low THC:high CBD product, or placebo by our collaborator in a separate study. Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coupon for a Discounted Placebo Product | Other | We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo. |
|
| Coupon for a Discounted High THC Product | Other | We will observe participants who were previously randomized to a coupon for discounted 4.29 mg THC/0.72 mg CBD soft-gel capsules by our collaborators, Vireo. |
|
| Coupon for a Discounted Equal THC and CBD Product | Other | We will observe participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by our collaborators, Vireo. |
|
| Coupon for a Discounted High CBD Product | Other | We will observe participants who were previously randomized to a coupon for discounted 0.25 mg THC/4.75 mg CBD soft-gel capsules by our collaborators, Vireo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receipt of Coupon for Placebo Soft-Gel Capsule | Other | 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 Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Severity Score | 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. | At weekly intervals from Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10) | 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. |
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Inclusion criteria:
->=18 years old
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Deepika E Slawek, MD, MPH, MS | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Health System | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | National Conference of State Legislatures. State Medical Marijuana Laws. Published 2020. Updated 11/6/2020. | ||
| Background | New York State Department of Health. Medical Use of Marijuana Under the Compassionate Care Act. In. Vol 22018. | ||
| 16209908 | Background | Russo E, Guy GW. A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Med Hypotheses. 2006;66(2):234-46. doi: 10.1016/j.mehy.2005.08.026. Epub 2005 Oct 4. | |
| 22115794 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Severity Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | At weekly intervals from Baseline to 14 weeks |
Up to approximately 14 weeks following intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Neuropathy | Nervous system disorders | Non-systematic Assessment |
The study did not reach its intended sample size as it was originally designed to enroll 100 participants. Accordingly, the study is underpowered and there may be limitations in the generalizability of results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deepika Slawek | Montefiore Medical Center | 718-920-3786 | dslawek@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2025 | Oct 29, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | Oct 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D009437 | Neuralgia |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| OTHER |
We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.
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|
| Receipt of Coupon for High THC Soft-Gel Capsule | Other | 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 Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps |
|
| Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule | Other | 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 Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps |
|
| Receipt of Coupon for High CBD Soft-Gel Capsule | Other | 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 Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps |
|
| From Baseline to 14 weeks |
| Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4) | 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. | From Baseline to 14 weeks |
| Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa) | 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. | From Baseline to 14 weeks |
| Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6) | 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. | From Baseline to 14 weeks |
| Change in Antiretroviral Medication Adherence Score | 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. | From Baseline to 14 weeks |
| Change in HIV Viral Load Suppression | 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. | From Baseline to 14 weeks |
| Change in Depression Score | 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. | From Baseline to 14 weeks |
| Change in Anxiety Score | 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. | From Baseline to 14 weeks |
| Background |
| Merlin JS, Cen L, Praestgaard A, Turner M, Obando A, Alpert C, Woolston S, Casarett D, Kostman J, Gross R, Frank I. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage. 2012 Mar;43(3):638-45. doi: 10.1016/j.jpainsymman.2011.04.019. Epub 2011 Nov 23. |
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| 37477975 | Background | Greene B, Bernardo L, Thompson M, Loughead J, Ashare R. Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial. JMIR Form Res. 2023 Jul 21;7:e47121. doi: 10.2196/47121. |
| Protocol Violation |
|
| No longer interested in participating |
|
| Lost to Follow-up |
|
| BG001 | Coupon for a Discounted High THC Product | 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 |
| BG002 | Coupon for a Discounted Equal THC and 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CD4 Count | Blood samples were collected at baseline for CD4 counts. CD4 counts measure the number of CD4 T-lymphocytes, a type of white blood cell crucial for a healthy immune system and can serve as an indicator of HIV progression as well as how effectively HIV medications are working. For people with HIV infection, a CD4 count between 500-1500 cells/microliter is considered normal, and a count <200 cells/microliter signals advanced immune damage. Results are summarized by study arm and reported in cells/microliter (cells/uL). | Baseline CD4 count results were unable to be obtained from 1 participant in the High CBD arm and 1 participant in the Placebo arm. | Mean | Standard Deviation | cells/uL |
|
| Pain Severity Score | Pain Severity was measured at baseline 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 using basic descriptive statistics. | Mean | Standard Deviation | score on a scale |
|
| Circulating levels of Pro-Inflammatory and Anti-inflammatory Cytokines | Circulating test levels of recent inflammation (based on a panel of inflammatory markers) was analyzed at baseline. Blood draws for circulating levels of pro-inflammatory (i.e., TNFa and IL-6) and anti-inflammatory (i.e., IL-10 and IL-6) 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. Baseline results for each cytokine type are summarized by study arm using basic descriptive statistics. | 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. | Mean | Standard Deviation | NPX value |
|
| Antiretroviral Medication Adherence Score | Antiretroviral medication adherence was assessed at baseline using the Visual Analog Scale (VAS) of antiretroviral therapy (ART) adherence. This is an ordinal scale representing the percentage of medication taken to what had been administered. Participants were presented with a visual ranging from 0%-100% scaled at 10% increments and asked to provide a best guess as to how much medicine was taken over the past 30 days with 0% signifying no medication, 50% signifying half, and 100% signifying that all medication was taken. Scores are summarized by study arm using descriptive statistics. | 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. | Mean | Standard Deviation | score on a scale |
|
| HIV Viral Load Suppression | HIV viral load was measured at baseline. Blood draws were obtained 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). A high HIV viral load in the blood is associated with increased risk of disease progression and HIV transmission. | Mean | Standard Deviation | copies/mL |
|
| Depression Score | Depression score was measured at baseline 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/frequency of depressive symptoms over the past week. Participants were asked to rate each of the 20 items on a 4-point Likert scale ranging from 0 ("Rarely/none of the time") to 3 ("Most/all of the time"), yielding an overall possible range of 0-60 (questions 4, 8, 12, and 16 were reverse-scored), such that higher scores indicated greater severity/frequency of depressive symptoms. | 4 participants did not complete the Depression questionnaire during baseline visit. No data from these participants was able to be collected/reported. | Mean | Standard Deviation | score on a scale |
|
| Anxiety Score | Anxiety score was measured at baseline 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 using basic descriptive statistics. | 4 participants did not complete the Anxiety questionnaire during baseline visit. No data from these participants was able to be collected/reported. | Mean | Standard Deviation | score on a scale |
|
| ID | Title | Description |
|---|
| OG000 | 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 |
| OG001 | Coupon for a Discounted High THC Product | 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 |
| OG002 | Coupon for a Discounted Equal THC and 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 |
| OG003 | 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 |
|
|
|
| Secondary | Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10) | 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. | Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients. | Posted | Mean | Standard Deviation | NPX value | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4) | 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. | Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients. | Posted | Mean | Standard Deviation | NPX value | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa) | 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. | Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients. | Posted | Mean | Standard Deviation | NPX value | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6) | 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. | Samples were not obtained from a number of participants at baseline and there were quality control issues with a couple of the samples. Accordingly, no change from baseline results data are available for these patients. | Posted | Mean | Standard Deviation | NPX value | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in Antiretroviral Medication Adherence Score | 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. | A number of participants bypassed this question stating that they did not want to answer and skipped over it in the baseline questionnaire. No change from baseline results data was able to be reported from these participants. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in HIV Viral Load Suppression | 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. | Samples were unable to be obtained from several participants at baseline. No change from baseline results data was able to be reported from these participants. | Posted | Mean | Standard Deviation | copies/mL | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in Depression Score | 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. | 4 participants did not complete the Depression questionnaire during baseline visit. No change from baseline results data was able to be reported from these participants. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 14 weeks |
|
|
|
|
| Secondary | Change in Anxiety Score | 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. | 4 participants did not complete the Anxiety questionnaire during baseline visit. No change from baseline results data was able to be reported from these participants. | Posted | Mean | Standard Deviation | score on a scale | From Baseline to 14 weeks |
|
|
|
|
| 0 |
| 9 |
| 1 |
| 9 |
| 1 |
| 9 |
| EG001 | Coupon for a Discounted High THC Product | 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 | 0 | 8 | 2 | 8 | 1 | 8 |
| EG002 | Coupon for a Discounted Equal THC and 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 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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