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Feasibility of a Randomized, Interventional Pilot Clinical Study of Oral Cannabinoids in People with HIV on Antiretroviral Therapy: CTNPT 028 Mboumba Bouassa, Ralph-Sydney; Needham, Judy; Nohynek, Dana; Samarani, Suzanne; Bobeuf, Florian; Del Balso, Lina; Paisible, Natalie; Vertzagias, Claude; Sebastiani, Giada; Margolese, Shari; Mandarino, Enrico; Singer, Joel; Klein, Marina B.; Lebouché, Bertrand; Cox, Joseph; Vulesevic, Branka; Müller, Alison; Lau, Elisa; Routy, Jean-Pierre; Jenabian, Mohammad-Ali; Costiniuk, Cecilia T.

Abstract

Cannabis-based medicines (CBMs) could help reduce systemic inflammation in people with HIV (PWH). In a prospective, randomized pilot study we enrolled participants from August 2021–April 2022 with HIV, aged ≥18 and on antiretroviral therapy and randomly assigned them to cannabidiol (CBD) ± Δ9-tetrahydrocannabinol (THC) capsules for 12 weeks with the primary objective being to assess safety and tolerability. Here we report on timeliness to study initiation, enrolment, compliance and retention rates. The target sample size was not reached. Two hundred and five individuals were approached, and 10 consented and were randomized; the rest refused (reasons: cannabis-related stigma/discomfort; too many study visits/insufficient time; unwillingness to undergo a “washout period” for three weeks) or were not eligible. The age of those randomized was 58 years (IQR 55–62); 80% were male. Only three met all criteria (30% enrolment compliance); seven were enrolled with minor protocol deviations. Compliance was excellent (100%). Eight (80%) participants completed the study; two (20%) were withdrawn for safety reasons (transaminitis and aggravation of pre-existing anemia). Time to study initiation and recruitment were the most challenging aspects. Ongoing work is required to reduce stigma related to CBMs. Future studies should find a balance between the requirements for safety monitoring and frequency of study visits.

Item Metadata

Title
Feasibility of a Randomized, Interventional Pilot Clinical Study of Oral Cannabinoids in People with HIV on Antiretroviral Therapy: CTNPT 028
Creator
Mboumba Bouassa, Ralph-Sydney; Needham, Judy; Nohynek, Dana; Samarani, Suzanne; Bobeuf, Florian; Del Balso, Lina; Paisible, Natalie; Vertzagias, Claude; Sebastiani, Giada; Margolese, Shari; Mandarino, Enrico; Singer, Joel; Klein, Marina B.; Lebouché, Bertrand; Cox, Joseph; Vulesevic, Branka; Müller, Alison; Lau, Elisa; Routy, Jean-Pierre; Jenabian, Mohammad-Ali; Costiniuk, Cecilia T.
Publisher
Multidisciplinary Digital Publishing Institute
Date Issued
2024-07-13
Description
Cannabis-based medicines (CBMs) could help reduce systemic inflammation in people with HIV (PWH). In a prospective, randomized pilot study we enrolled participants from August 2021–April 2022 with HIV, aged ≥18 and on antiretroviral therapy and randomly assigned them to cannabidiol (CBD) ± Δ9-tetrahydrocannabinol (THC) capsules for 12 weeks with the primary objective being to assess safety and tolerability. Here we report on timeliness to study initiation, enrolment, compliance and retention rates. The target sample size was not reached. Two hundred and five individuals were approached, and 10 consented and were randomized; the rest refused (reasons: cannabis-related stigma/discomfort; too many study visits/insufficient time; unwillingness to undergo a “washout period” for three weeks) or were not eligible. The age of those randomized was 58 years (IQR 55–62); 80% were male. Only three met all criteria (30% enrolment compliance); seven were enrolled with minor protocol deviations. Compliance was excellent (100%). Eight (80%) participants completed the study; two (20%) were withdrawn for safety reasons (transaminitis and aggravation of pre-existing anemia). Time to study initiation and recruitment were the most challenging aspects. Ongoing work is required to reduce stigma related to CBMs. Future studies should find a balance between the requirements for safety monitoring and frequency of study visits.
Subject
cannabis research; feasibility; barriers; recruitment
Genre
Article
Type
Text
Language
eng
Date Available
2024-08-02
Provider
Vancouver : University of British Columbia Library
Rights
CC BY 4.0
DOI
10.14288/1.0444980
URI
http://hdl.handle.net/2429/88860
Affiliation
Medicine, Faculty of; Non UBC; Population and Public Health (SPPH), School of
Citation
Journal of Personalized Medicine 14 (7): 745 (2024)
Publisher DOI
10.3390/jpm14070745
Peer Review Status
Reviewed
Scholarly Level
Faculty; Researcher
Rights URI
https://creativecommons.org/licenses/by/4.0/
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CC BY 4.0