Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2022-10-28
2024-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Coupon for a Discounted Placebo Product
We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.
Receipt of Coupon for Placebo Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps
Coupon for a Discounted High THC Product
We will observe participants who were previously randomized to a coupon for discounted 4.29 mg THC/0.72 mg CBD soft-gel capsules by our collaborators, Vireo.
Receipt of Coupon for High THC Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps
Coupon for a Discounted Equal THC and CBD Product
We will observe participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by our collaborators, Vireo.
Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps
Coupon for a Discounted High CBD Product
We will observe participants who were previously randomized to a coupon for discounted 0.25 mg THC/4.75 mg CBD soft-gel capsules by our collaborators, Vireo.
Receipt of Coupon for High CBD Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps
Interventions
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Receipt of Coupon for Placebo Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps
Receipt of Coupon for High THC Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps
Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps
Receipt of Coupon for High CBD Soft-Gel Capsule
The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
100 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Colorado, Boulder
OTHER
University of Pittsburgh
OTHER
Vireo Health
OTHER
Montefiore Medical Center
OTHER
Responsible Party
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Principal Investigators
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Deepika E Slawek, MD, MPH, MS
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Health System
The Bronx, New York, United States
Countries
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References
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Bonn-Miller MO, Oser ML, Bucossi MM, Trafton JA. Cannabis use and HIV antiretroviral therapy adherence and HIV-related symptoms. J Behav Med. 2014 Feb;37(1):1-10. doi: 10.1007/s10865-012-9458-5. Epub 2012 Oct 7.
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Greene B, Bernardo L, Thompson M, Loughead J, Ashare R. Behavioral Economic Strategies to Improve Enrollment Rates in Clinical Research: Embedded Recruitment Pilot Trial. JMIR Form Res. 2023 Jul 21;7:e47121. doi: 10.2196/47121.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2021-13662
Identifier Type: -
Identifier Source: org_study_id