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Pain Inflammation and Cannabis in HIV
Pain Inflammation and Cannabis in HIV

NCT05554146

CompletedNA

Sponsor: Montefiore Medical Center

Conditions: HIV Infections, Neuropathic Pain, Cannabis

Interventions: Receipt of Coupon for Placebo Soft-Gel Capsule, Receipt of Coupon for High THC Soft-Gel Capsule, Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule, Receipt of Coupon for High CBD Soft-Gel Capsule

Countries: United States

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 tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • The Bronx, New York, United States