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.
Brief Title
Pain, Inflammation, and Cannabis in HIV
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
HIV Infections
Neuropathic Pain
Cannabis
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
* \>= 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
Inclusion 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
* \>= 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04860089
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10394
Overall Status
Withdrawn
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
Primary Outcomes
Outcome Description
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.
Outcome Measure
Pain severity
Outcome Time Frame
14 weeks
Secondary Ids
Secondary Id
GRANT13267147
Secondary Id
1K23DA053997-01A1
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
14 weeks
Outcome Measure
Circulating levels of inflammatory cytokines
Outcome Description
Measured at 0 and 14 weeks Visual Analog Scale \[VAS\] (0-100) with higher number indicating better adherence.
Outcome Time Frame
14 weeks
Outcome Measure
Antiretroviral adherence
Outcome Description
HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)
Outcome Time Frame
14 weeks
Outcome Measure
HIV Viral load suppression
Outcome Description
Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 \[PHQ-9\] (0-27) with higher score indicating worse depression
Outcome Time Frame
14 weeks
Outcome Measure
Depression
Outcome Description
Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 \[GAD-7\] (0-21) with higher score indicating worse anxiety
Outcome Time Frame
14 weeks
Outcome Measure
Anxiety
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Adults with HIV and neuropathic pain, who are not taking opioids and are actively certified for medical cannabis in New York
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Deepika Slawek
Investigator Email
dslawek@montefiore.org
Investigator Phone
512-947-6438