None listed
Conditions
Brief summary
Medicinal cannabis predominantly containing cannabidiol (CBD) is often prescribed for the relief of cancer symptoms. However, it is illegal to drive in Queensland while taking tetrahydrocannabinol (THC) irrespective of whether it is for recreational or medicinal use. Unfortunately, very few CBD dominant products are completely free of THC, with most products containing traces of THC. Whether a CBD-dominant preparation with trace THC taken as an oil preparation would return a positive result on a roadside screening test is an important gap in the literature. Therefore, the aim of this study is to assess whether THC is detectable in saliva, blood, and urine after administration of CBD-dominant medicinal cannabinoid preparations in cancer patients. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with cancer, are known to the Cancer Care Service, and are experiencing cancer-related symptoms. Study details Participants will be allocated to one of three treatment groups based upon doctor/patient preference and product availability, involving either LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL), LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL), or LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) administered as an oral solution. Treatment will be administered for a total of 27 days, starting at a dose of 0.25ml daily and increasing every 3 days for the first 14 days, reaching a max dose of 1ml twice a day. The day 14 dose is then continued for days 15 - 27. If the participant experiences adverse effects, the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants will be asked to return for study visits on days 7, 14, and 28 after commencing the treatment to collect saliva, urine, and blood samples for the detection of THC. During these visits, questionnaires regarding cancer symptoms will also be completed, as well as an assessment of any adverse effects experienced as a result of treatment. It is hoped that this study may show that CBD-dominant preparations do not produce a detectable level of THC in clinical samples, while showing an improvement in cancer symptoms with minimal side effects. This may help to inform advice given to patients taking medicinal cannabinoid preparations in future.
Interventions
Participants will be offered a 50mL bottle of LGP Classic CBD 50, LGP Classic 1:100 or LGP Classic 1:20 according to doctor/patient preference and product availability.
LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL) oral solution (dose range 0.05mg/12.5mg - 0.4mg/100mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will in
Participants will be offered a 50mL bottle of LGP Classic CBD 50, LGP Classic 1:100 or LGP Classic 1:20 according to doctor/patient preference and product availability. LGP Classic CBD 50 (THC/CBD 0.2mg/50mg per mL) oral solution (dose range 0.05mg/12.5mg - 0.4mg/100mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle. LGP Classic 1:100 (THC/CBD 1.5mg/100mg per mL) oral solution (dose range 0.375mg/25mg - 3mg/200mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle. LGP Classic CBD 1:20 (THC/CBD 1mg/20mg per mL) oral solution (dose range 0.25mg/5mg - 2mg/40mg) per day. Dosing commences at 0.25ml daily increasing every 3 days for the first 14 days; reaching a max dose of 1ml twice a day. Between days 0 and 11 the dose will increase by 0.25mls every 3 days. Day 12 to 15 the dose will increase by 0.5mls every 3 days. The day 14 dose is then continued for day 15 - 27. If the participant experienced adverse effects the dose can be reduced to the previously tolerated dose. If the dose is effective prior to day 14, continued titration is not required. Participants are required to bring the study drug to each study visit for monitoring and compliance of mls (volume) remaining in the bottle.
Sponsors
Mater Misericordiae Limited
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with histologically proven cancer known to the Cancer Care Service who: - Have had an ESAS TSDS greater than or equal to 10 for cancer or cancer-treatment-related symptoms, and at least one individual ESAS score greater than or equal to 3 - Performance Status AKPS (Australia-modified Karnofsky Scale score) of greater than or equal to 30 - Aged 18 years, English-speaking (or have an interpreter available) - Have a negative THC urine test at baseline - Have a negative pregnancy urine test at eligibility (only if of reproductive potential) and agree to avoid pregnancy during the study and 12 weeks following the last dose of the study drug. Males must agree to avoid fathering a child and to not donate sperm during the study and for at least 12 weeks following the last dose of the study drug - Are able to tolerate oral medications - Are willing to receive standard palliative care as necessary and delivered by their primary treating team - Physician assessed ability to comply with all trial requirements, agree to attend scheduled clinic appointments and adhere to dose titration schedules as directed - Agree to use no other cannabis-based products for the duration of the trial - Understand that it is illegal to drive whilst taking THC containing cannabis products, to take cannabinoid products outside of Australia or to endorse legal documents whilst taking THC containing cannabis products - Able to provide fully informed consent
Exclusion criteria
Patients with: - A history of hypersensitivity to any cannabinoid - Unstable untreated cardiovascular disease (hypertension, ischaemic heart disease, congestive cardiac failure) - Severe hepatic impairment (total bilirubin greater than or equal to 1.5 times the upper limit of the institution’s normal range. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than or equal to 3.0 time the upper limit of the institution’s normal range; subjects with liver metastasis AST and ALT of greater than or equal to 5.0 times the upper limit of normal - Severe renal impairment (eGFR greater than or equal to 20mL/min/1.73m2) - A history of psychiatric disorders (severe depression or anxiety, personality disorder, psychosis, schizophrenia) - Known substance use disorder (ASSIST - Alcohol, Smoking and Substance Involvement Screening Test) examination scoring greater than or equal to 27 for any substance - History suggesting that drug diversion may be a risk for them or their family/carers - Females who are pregnant or lactating - Concurrent or participation in a trial of a new clinical entity within the last 28 days - Treatment with a new specific anticancer agent (chemotherapy, hormone therapy, targeted or immunotherapy or radiation within the last 7 days
Outcome results
None listed