Pain Inflammation and Cannabis in HIV

HIV Infections Clinical Trial

— PITCH-E  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05554146
• Other study ID #: 2021-13662
• Secondary ID: K23DA053997
• Status: Completed
• Phase: N/A
• Start date: October 28, 2022
• Est. completion date: May 3, 2024

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 3, 2024
• Est. primary completion date: May 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cannabis
• HIV Infections
• Inflammation
• Marijuana Abuse
• Neuralgia
• Neuropathic Pain

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Montefiore Health System	Bronx	New York

Sponsors (4)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute on Drug Abuse (NIDA), University of Colorado, Boulder, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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