Cannabis Treatment for Chronic Pain version1
Research type
Research Study
Full title
A NON-RANDOMISED, NON-BLINDED STUDY OF THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF A CANNABIS BASED MEDICINAL PRODUCT (CBMP) FOR THE TREATMENT OF CHRONIC NON-CANCER PAIN COMPARED AGAINST EACH PARTICIPANTS BASE LINE RESULTS.
IRAS ID
329912
Contact name
James Short
Contact email
Sponsor organisation
Celadon Pharmaceuticals plc
Eudract number
2019-003035-34
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT, 2019-003035-34
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
The primary purpose of this study is to determine whether the addition of a certain strain of cannabis flower when added to the standard of care for chronic non cancer pain patients is safe, tolerable and has a beneficial improvement in the patients pain levels. Secondary purposes of this study would be to look at improvement in the quality of sleep, opioid reduction and quality of life changes.
The study will recruit male and female patients aged 18 to 85 years old in the UK that suffer from chronic pain and for whom standard of care treatment is not effective in alleviating their pain situation.
Patients will continue to receive their standard of care, if any, from the NHS and will be provided with the cannabis additional treatment from the study sites. The study sites will monitor and manage the participants for cannabis related issues of the treatment. The cannabis flower will come in pre sealed tamper proof cartridges that are placed into a specialised inhalation device. The pre filled cartridges and inhalation device will be provided for free to the participants by the study sites. Participants will be reimbursed for some of their costs of participating in the study.
Participants in the study will be required to consent to be involved in the study and agree to their data being used to analyse the results of the study. Participants will be required to fill in questionnaires on a regular basis over the term of the study such as safety questionnaires and pain scores, sleep patterns and quality of life. The participants will take their cannabis medication in the morning and evening. The study will last for a term of 18 months from first patient in to last patient out.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0234
Date of REC Opinion
1 Aug 2023
REC opinion
Further Information Favourable Opinion