PITCH-E: Pain Inflammation and Cannabis in HIV
Study Details
Study Description
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 study how varying ratios of THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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,
- 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Pain severity [14 weeks]
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.
Secondary Outcome Measures
- Circulating levels of inflammatory cytokines [14 weeks]
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
- Antiretroviral adherence [14 weeks]
Measured at 0 and 14 weeks Visual Analog Scale [VAS] (0-100) with higher number indicating better adherence.
- HIV Viral load suppression [14 weeks]
HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)
- Depression [14 weeks]
Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 [PHQ-9] (0-27) with higher score indicating worse depression
- Anxiety [14 weeks]
Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 [GAD-7] (0-21) with higher score indicating worse anxiety
Eligibility Criteria
Criteria
Inclusion Criteria:
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= 18 years old
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Diagnosis of HIV
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Fluency in English
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Active certification for medical cannabis
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No medical cannabis dispensed or used within the previous 30 days
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Intends to purchase soft-gel capsule medical cannabis at Vireo
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ICD-10 (International Classification of Diseases 10th Revision) diagnosis code for neuropathic pain, OR
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Neuropathic pain in problem list of electronic medical record, OR
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Neuropathic pain questionnaire-short form>0
Exclusion Criteria:
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Inability to provide informed consent
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Inability to complete 14 weeks of study visits
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Medical cannabis use within 30 days prior to enrollment
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Unique pain symptoms (e.g. multiple sclerosis, rheumatoid arthritis)
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Terminal illness
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Current or prior psychotic disorder
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Street cannabis, opioid, cocaine, or benzodiazepine use in the past 30 days
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Dispensed opioids of benzodiazepines within 60 days
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Non-steroidal anti-inflammatory use within 7 days prior to enrollment
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Steroid use within the past 14 days with duration of therapy >=21 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montefiore Health System | Bronx | New York | United States | 10467 |
Sponsors and Collaborators
- Montefiore Medical Center
- National Institute on Drug Abuse (NIDA)
- University of Colorado, Boulder
- University of Pittsburgh
Investigators
- Principal Investigator: Deepika E Slawek, MD, MPH, MS, Montefiore Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-13662
- K23DA053997