Pain, Inflammation, and Cannabis in HIV

Montefiore Medical Center

Overview

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and 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. We 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) (including a high THC:low CBD product, an equal THC:CBD product, and a low THC:high CBD product). 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

OBSERVATIONAL

Conditions

HIV Infections Neuropathic Pain Cannabis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * \>= 18 years old * Diagnosis of HIV * Fluency in English * Active certification for medical cannabis * No medical cannabis dispensed or used within the previous 30 days * Intends to purchase soft-gel capsule medical cannabis at Vireo * ICD-10 diagnosis code for neuropathic pain, OR * Neuropathic pain in problem list of electronic medical record, 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 30 days prior to enrollment * Unique pain symptoms (e.g. multiple sclerosis, rheumatoid arthritis) * Terminal illness * Current or prior psychotic disorder * Street cannabis, opioid, cocaine, or benzodiazepine use in the past 30 days * Dispensed opioids of benzodiazepines within 60 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

Outcomes

Primary Outcomes

Pain severity

self-reported pain severity measured via the Brief Pain Interference (BPI) severity scale (1-10) with higher score indicating worse pain. Measured weekly with web- or phone-based questionnaire.

Time frame: 14 weeks

Secondary Outcomes

Circulating levels of inflammatory cytokines

Tests levels of recent inflammation (panel of inflammatory markers) at two time points before starting medical cannabis and 14 weeks after starting medical cannabis. Reported in pg/mL

Time frame: 14 weeks

Antiretroviral adherence

Measured at 0 and 14 weeks Visual Analog Scale \[VAS\] (0-100) with higher number indicating better adherence.

Time frame: 14 weeks

HIV Viral load suppression

HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)

Time frame: 14 weeks

Depression

Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 \[PHQ-9\] (0-27) with higher score indicating worse depression

Time frame: 14 weeks

Anxiety

Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 \[GAD-7\] (0-21) with higher score indicating worse anxiety

Time frame: 14 weeks

Data from ClinicalTrials.gov

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