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. The investigators will observe how varying ratios of THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections; Cannabis; Neuropathic Pain
• Intervention / Treatment: Other: Receipt of Coupon for Placebo Soft-Gel Capsule; Other: Receipt of Coupon for High THC Soft-Gel Capsule; Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule; Other: Receipt of Coupon for High CBD Soft-Gel Capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deepika E Slawek, MD, MPH, MS; Phone Number: 718-920-3786; Email: dslawek@montefiore.org
• Study Contact Backup: Name: Giovanna DiFrancesca; Phone Number: 718-920-5763; Email: giovanna.calderon@einsteinmed.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Coupon for a Discounted Placebo Product; We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.	Other: Receipt of Coupon for Placebo Soft-Gel Capsule; The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Other: Coupon for a Discounted High THC Product; We will observe participants who were previously randomized to a coupon for discounted 4.3 mg THC/0.7 mg CBD soft-gel capsules by our collaborators, Vireo.	Other: Receipt of Coupon for High THC Soft-Gel Capsule; The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Other: Coupon for a Discounted Equal THC and CBD Product; 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.	Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule; The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Other: Coupon for a Discounted High CBD Product; We will observe participants who were previously randomized to a coupon for discounted 0.2 mg THC/4.8 mg CBD soft-gel capsules by our collaborators, Vireo.	Other: Receipt of Coupon for High CBD Soft-Gel Capsule; The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study

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
• Investigators: Principal Investigator: Deepika E Slawek, MD, MPH, MS, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: 2021-13662; K23DA053997 (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