Pain, Inflammation, and Cannabis in HIV (PITCH-E)

Montefiore Medicine Academic Health System

Status: Withdrawn

Conditions: Cannabis; Neuropathic Pain; HIV Infections

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04860089

2019-10394

GRANT13267147 (Other Grant/Funding Number)

1K23DA053997-01A1

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. We will study how varying ratios of THC and 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. 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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