Feasibility of a cannabidiol-dominant cannabis-based medicinal product for the treatment of long COVID symptoms: A single-arm open-label feasibility trial.
Hannah Thurgur, Michael T. Lynskey, Anne Katrin Schlag, Carol Croser, David John Nutt, Elizabeth Iveson
British Journal of Clinical Pharmacology January 17, 2024 DOI: 10.1111/bcp.15988 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Single-arm open-label feasibility trial Peer reviewed |
|---|---|
| Sample size | 12 |
| Population | Individuals diagnosed with long COVID |
| Dose | up to 3 mL per day orally (50 mg CBD/mL, <2 mg δ-9-tetrahydrocannabinol/mL) |
| Duration | 21-week treatment phase followed by ~3 weeks without the study drug |
| Topics | Cannabis CBD |
| Keywords | Long covid treatment Post-covid condition therapy Chronic covid management Long-haul covid remedy Long covid alleviation Cannabidiol CBD CBD Product Cannabis extract Cannabinoid therapy Symptom management Pain relief Fatigue reduction Sleep improvement Anxiety alleviation Symptom control Quality of life Well-being enhancement Daily life improvement Life quality boost |
| Citations | 7 |
| Key findings | The CBD-dominant cannabis-based medicinal product was safe and well-tolerated in 12 people with long COVID, with full adherence and no serious adverse events, indicating feasibility of this treatment approach. The authors report that recruitment strategy limitations showed a lack of feasibility in the approach used, and that larger samples and a control group are needed to test efficacy. |
Abstract
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.
Comparable studies
Other non-randomized and open-label trials on CBD, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Preventing new substance use behaviors in youth: evaluation of a two-year comprehensive program. Association workers and young people in France | 2024 | Pre-post intervention evaluation | n = 666 |
| Daily Cannabidiol Administration for 10 Weeks Modulates Hippocampal and Amygdalar Resting-State Functional Connectivity in Cannabis Users: A Functional Magnetic Resonance Imaging Open-Label Clinical Trial People who use cannabis | 2023 | Open-label pragmatic trial | n = 18 |
| Human Pharmacokinetics and Adverse Effects of Pulmonary and Intravenous THC-CBD Formulations Healthy volunteers | 2018 | Open-label, 2-period phase-1 pharmacokinetic study | n = 11 |
| Therapeutic Effects of Prolonged Cannabidiol Treatment on Psychological Symptoms and Cognitive Function in Regular Cannabis Users: A Pragmatic Open-Label Clinical Trial. Community sample of regular cannabis users (16 male, median age 25 years; majority... | 2018 | Open-label pragmatic trial | n = 20 |