Pain Inflammation and Cannabis in HIV (PITCH-E)

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Cannabis; Neuropathic Pain; HIV Infections

Treatments: Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule; Other: Receipt of Coupon for High CBD Soft-Gel Capsule; Other: Receipt of Coupon for High THC Soft-Gel Capsule; Other: Receipt of Coupon for Placebo Soft-Gel Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05554146

K23DA053997 (U.S. NIH Grant/Contract)

2021-13662

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 4 patient groups

Coupon for a Discounted Placebo Product

Other group

Description:

We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.

Treatment:

Other: Receipt of Coupon for Placebo Soft-Gel Capsule

Coupon for a Discounted High THC Product

Other group

Description:

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.

Treatment:

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

Coupon for a Discounted Equal THC and CBD Product

Other group

Description:

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.

Treatment:

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

Coupon for a Discounted High CBD Product

Other group

Description:

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.

Treatment:

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