Feasibility of a cannabidiol-dominant cannabis-based medicinal product for the treatment of long COVID symptoms : A single-arm open-label feasibility trial
© 2023 British Pharmacological Society..
AIMS: To conduct a single-arm open-label feasibility trial of the safety and tolerability of a full-spectrum cannabidiol (CBD)-dominant cannabis-based medicinal product for treating the symptoms of long COVID.
METHODS: The treatment phase ran for a total of 21 weeks, followed by ~3 weeks without the study drug. Participants received up to 3 mL of MediCabilis 5% CBD Oil (50 mg CBD/mL, <2 mg δ-9-tetrahydrocannabinol/mL) per day orally. Monthly patient-reported outcome measures of common symptoms and daily self-report of symptoms were collected via a smartphone app. Key measures of heart rate, activity, sleep and oxygen saturation were assessed using wearable technology.
RESULTS: Twelve (1 male, 11 female) individuals diagnosed with long COVID were recruited into the trial. All participants adhered to the treatment protocol for the duration of the study and there were no serious adverse events. Response rates for the research assessments were high with over 90% completion of patient-reported outcome measures and daily self-report.
CONCLUSION: The study drug was safe and well-tolerated, demonstrating feasibility of CBD-dominant cannabis-based medicinal products in individuals diagnosed with long COVID. However, there were limitations in research design related to recruitment strategy demonstrating a lack of feasibility in the approach implemented in this study. Future work with larger samples and incorporating a control group are required to test the efficacy of this treatment.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:90 |
|---|---|
| Enthalten in: |
British journal of clinical pharmacology - 90(2024), 4 vom: 07. März, Seite 1081-1093 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Thurgur, Hannah [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
19GBJ60SN5 |
|---|
| Anmerkungen: |
Date Completed 29.03.2024 Date Revised 29.03.2024 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1111/bcp.15988 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM365963445 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM365963445 | ||
| 003 | DE-627 | ||
| 005 | 20240330000642.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231227s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1111/bcp.15988 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1355.xml |
| 035 | |a (DE-627)NLM365963445 | ||
| 035 | |a (NLM)38105651 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Thurgur, Hannah |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Feasibility of a cannabidiol-dominant cannabis-based medicinal product for the treatment of long COVID symptoms |b A single-arm open-label feasibility trial |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 29.03.2024 | ||
| 500 | |a Date Revised 29.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 British Pharmacological Society. | ||
| 520 | |a AIMS: To conduct a single-arm open-label feasibility trial of the safety and tolerability of a full-spectrum cannabidiol (CBD)-dominant cannabis-based medicinal product for treating the symptoms of long COVID | ||
| 520 | |a METHODS: The treatment phase ran for a total of 21 weeks, followed by ~3 weeks without the study drug. Participants received up to 3 mL of MediCabilis 5% CBD Oil (50 mg CBD/mL, <2 mg δ-9-tetrahydrocannabinol/mL) per day orally. Monthly patient-reported outcome measures of common symptoms and daily self-report of symptoms were collected via a smartphone app. Key measures of heart rate, activity, sleep and oxygen saturation were assessed using wearable technology | ||
| 520 | |a RESULTS: Twelve (1 male, 11 female) individuals diagnosed with long COVID were recruited into the trial. All participants adhered to the treatment protocol for the duration of the study and there were no serious adverse events. Response rates for the research assessments were high with over 90% completion of patient-reported outcome measures and daily self-report | ||
| 520 | |a CONCLUSION: The study drug was safe and well-tolerated, demonstrating feasibility of CBD-dominant cannabis-based medicinal products in individuals diagnosed with long COVID. However, there were limitations in research design related to recruitment strategy demonstrating a lack of feasibility in the approach implemented in this study. Future work with larger samples and incorporating a control group are required to test the efficacy of this treatment | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a cannabidiol | |
| 650 | 4 | |a cannabis‐based medicinal products | |
| 650 | 4 | |a long COVID | |
| 650 | 4 | |a medical cannabis | |
| 650 | 4 | |a post‐coronavirus disease‐19 syndrome | |
| 650 | 7 | |a Cannabidiol |2 NLM | |
| 650 | 7 | |a 19GBJ60SN5 |2 NLM | |
| 650 | 7 | |a Hallucinogens |2 NLM | |
| 650 | 7 | |a Dronabinol |2 NLM | |
| 650 | 7 | |a 7J8897W37S |2 NLM | |
| 700 | 1 | |a Lynskey, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Schlag, Anne Katrin |e verfasserin |4 aut | |
| 700 | 1 | |a Croser, Carol |e verfasserin |4 aut | |
| 700 | 1 | |a Nutt, David John |e verfasserin |4 aut | |
| 700 | 1 | |a Iveson, Elizabeth |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t British journal of clinical pharmacology |d 1974 |g 90(2024), 4 vom: 07. März, Seite 1081-1093 |w (DE-627)NLM000097799 |x 1365-2125 |7 nnns |
| 773 | 1 | 8 | |g volume:90 |g year:2024 |g number:4 |g day:07 |g month:03 |g pages:1081-1093 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1111/bcp.15988 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 90 |j 2024 |e 4 |b 07 |c 03 |h 1081-1093 | ||