Clinical trial NCT04860089: Pain, Inflammation, and Cannabis in HIV
Official title: The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
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
name: Vireo Health
First posted: 2021-04-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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. We will study how varying ratios of THC and CBD 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. 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.

Eligibility criteria: 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

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:
Study officials:
affiliation: Montefiore Medical Center
name: Deepika E Slawek, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: