Clinical trial NCT05554146: Pain Inflammation and Cannabis in HIV
Official title: The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Neuropathic Pain
Cannabis
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Colorado, Boulder
name: University of Pittsburgh
First posted: 2022-09-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.
Primary purpose: TREATMENT

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. The investigators will observe how varying ratios of THC (tetrahydrocannabinol) and CBD (cannabidiol) 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. 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.

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.

Primary outcomes:
measure: Pain severity
timeFrame: 14 weeks
Secondary outcomes:
measure: Circulating levels of inflammatory cytokines
timeFrame: 14 weeks
measure: Antiretroviral adherence
timeFrame: 14 weeks
measure: HIV Viral load suppression
timeFrame: 14 weeks
measure: Depression
timeFrame: 14 weeks
measure: Anxiety
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Health System
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Deepika E Slawek, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: