Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-24 @ 2:10 PM
NCT ID:
NCT04997395
Brief Summary:
This is an open label, phase 2 clinical trial to assess the feasibility of a cannabidiol (CBD) dominant medicinal cannabis for the treatment of Long COVID. The primary aim is to assess the feasibility of recruiting and retaining individuals diagnosed with Long COVID into a treatment trial of medicinal cannabis, as well as assessing the safety and tolerability of a dominant medicinal cannabis in this population. The secondary aim is to determine the effect of a CBD dominant medicinal cannabis on symptoms associated with Long COVID.
Detailed Description:
Long COVID, also defined as post-COVID-19 syndrome, is a common outcome after infection with the SARS-COV-2 virus. The need for treatment and ongoing support for people experiencing Long COVID has been increasingly recognised, including through the establishment of dedicated treatment units within the NHS. While symptoms and their severity may vary greatly between individuals, some of the common symptoms associated with Long COVID include fatigue, breathlessness, pain, sleep disturbances and dysautonomia. In this study, we will test the feasibility of a broad spectrum cannabidiol (CBD) dominant formulation, MediCabilis Cannabis sativa 50, for treating these symptoms in people with a diagnosis of Long COVID. CBD is the primary non-psychoactive ingredient in cannabis, and it is being increasingly used in the treatment of symptoms which are similar to those associated with Long COVID. Additionally, there is some evidence that CBD may be effective in reducing inflammation associated with COVID infection. Together, this evidence suggests that it is possible that CBD may be an effective treatment for people diagnosed with Long COVID. We will therefore conduct a feasibility trial in which 30 people are prescribed CBD dominant medical cannabis. Patients will take this medication daily for a total of 21 weeks (2-week titration period, 18-weeks steady dose, 1-week dose reduction), followed by 3-weeks with no medication. We will collect monthly self-report assessments of common symptoms including breathlessness, fatigue, mood, cognition and pain via a smartphone app, as well as real-time data on heart rate, physical activity and sleep using wearable technology. We will also collect daily self-report assessments of key symptoms (mood, pain, fatigue and breathlessness) via a smartphone app for 7 days per 28 days. Our study will establish whether it is feasible to recruit and retain patients with a diagnosis of Long COVID into a trial of a CBD dominant medical cannabis. We will also monitor whether there are any side effects to assess the safety and tolerability of a CBD dominant medical cannabis. Our results will determine the feasibility of medicinal cannabis in the treatment of Long COVID and whether it is safe to use.
Study:
NCT04997395
Study Brief:
Protocol Section:
NCT04997395