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

The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV Infections; Cannabis; Neuropathic Pain

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with HIV and neuropathic pain, who are not taking opioids and are actively certified for medical cannabis in New York

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	14 weeks
Antiretroviral adherence	Measured at 0 and 14 weeks Visual Analog Scale [VAS] (0-100) with higher number indicating better adherence.	14 weeks
HIV Viral load suppression	HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)	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	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	14 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 12, 2023
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Substance-Related Disorders; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Inflammation; Neuralgia; Marijuana Abuse
• Other Study ID Numbers: 2019-10394; GRANT13267147 (Other Grant/Funding Number: NIDA); 1K23DA053997-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No