Pain Inflammation and Cannabis in HIV

NCT05554146 | Completed Results DMC

• 2 other identifiers: 2021-13662K23DA053997
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; Neuropathic Pain; Cannabis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10)

  From Baseline to 14 weeks

• Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4)

  From Baseline to 14 weeks

• Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa)

  From Baseline to 14 weeks

• Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6)

  From Baseline to 14 weeks

• Change in Antiretroviral Medication Adherence Score

  From Baseline to 14 weeks

Study Arms (4)

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.

Other: Receipt of Coupon for Placebo Soft-Gel Capsule

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.

Other: Receipt of Coupon for High THC Soft-Gel Capsule

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.

Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule

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.

Other: Receipt of Coupon for High CBD Soft-Gel Capsule

Interventions

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

Coupon for a Discounted Placebo Product

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

Coupon for a Discounted High THC Product

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

Coupon for a Discounted Equal THC and CBD Product

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

Coupon for a Discounted High CBD Product

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Colorado, Boulder: collaborator
• University of Pittsburgh: collaborator
• Vireo Health: collaborator

Study Sites (1)

Montefiore Health System

The Bronx, New York, 10467, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

HIV Infections; Neuralgia; Marijuana Abuse

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Deepika Slawek
• Organization: Montefiore Medical Center

dslawek@montefiore.org

718-920-3786

Study Officials

• Deepika E Slawek, MD, MPH, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: October 28, 2022
• Primary Completion: May 3, 2024
• Study Completion: May 3, 2024
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)