Pain, Inflammation, and Cannabis in HIV

Withdrawn

• Conditions: Cannabis; HIV Infections; Neuropathic Pain

• Registration Number: NCT04860089
• Lead Sponsor: Montefiore Medical Center

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. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-21
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-26
• Study Start: 2022-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-12-12
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain severity	14 weeks	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.

Secondary Outcome Measures

Name	Time	Method
HIV Viral load suppression	14 weeks	HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)
Circulating levels of inflammatory cytokines	14 weeks	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
Depression	14 weeks	Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 \[PHQ-9\] (0-27) with higher score indicating worse depression
Antiretroviral adherence	14 weeks	Measured at 0 and 14 weeks Visual Analog Scale \[VAS\] (0-100) with higher number indicating better adherence.
Anxiety	14 weeks	Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 \[GAD-7\] (0-21) with higher score indicating worse anxiety