Assessing the ability to detect tetrahydrocannabinol (THC) from cannabidiol (CBD) dominant medicinal cannabis products in patient samples of saliva, blood, and urine

Phase 3

Recruiting

• Conditions: Cancer; Cancer - Any cancer

• Registration Number: ACTRN12622000974707
• Lead Sponsor: Mater Misericordiae Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-11
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified