Pain Inflammation and Cannabis in HIV (PITCH-E)

The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; Cannabis; Neuropathic Pain
• Intervention / Treatment: Other: Receipt of Coupon for Placebo Soft-Gel Capsule; Other: Receipt of Coupon for High THC Soft-Gel Capsule; Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule; Other: Receipt of Coupon for High CBD Soft-Gel Capsule

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • The Bronx, New York, United States, 10467
      • Montefiore Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Adults with HIV and neuropathic pain, who are not taking opioids and are actively certified for medical cannabis in New York.

Description

Inclusion criteria:

->=18 years old

• Diagnosis of HIV
• Fluency in English
• Active certification for medical cannabis
• ICD-10 diagnosis code for neuropathic pain, OR Neuropathic pain in problem list of electronic medical record, OR Neuropathic pain per medical cannabis certification form, OR Neuropathic Pain Questionnaire-Short Form>0

Exclusion Criteria:

• Inability to provide informed consent
• Inability to complete 14 weeks of study visits
• Medical cannabis use within 14 days of enrollment, and no medical cannabis dispensed within 30 days of enrollment
• Unique pain symptoms (e.g., multiple sclerosis, rheumatoid arthritis)
• Terminal illness
• Current or prior psychotic disorder
• Unregulated cannabis use in the past 14 days; opioid or cocaine use in the past 30 days
• Dispensed opioids within 30 days
• Non-steroidal anti-inflammatory use within 7 days prior to enrollment
• Steroid use within the past 14 days with duration of therapy >=21 days
• COVID vaccination or booster within 14 days of screening
• Active or acute cardiac disease based on clinician chart review.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Coupon for a Discounted Placebo Product; We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.	Other: 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 Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps
Other: Coupon for a Discounted Equal THC and CBD Product; 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.	Other: 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 Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps
Other: Coupon for a Discounted High THC Product; 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.	Other: 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 Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps
Other: Coupon for a Discounted High CBD Product; 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.	Other: 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 Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute on Drug Abuse (NIDA); University of Pittsburgh; University of Colorado, Boulder; Vireo Health
• Investigators: Principal Investigator: Deepika E Slawek, MD, MPH, MS, Montefiore Medical Center

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neuromuscular Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Peripheral Nervous System Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; HIV Infections; Neuralgia; Marijuana Abuse; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 2021-13662; K23DA053997 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No