None listed
Conditions
Brief summary
This is a research study examining whether medicinal cannabis can safely be given to people who are having a surgical procedure involving the bowel. When a person undergoes major surgery on the abdomen, care after the surgery involves the administration of medications that help relieve pain associated with the surgical procedure. Some of these drugs are called “opioids”. Most patients in this study will probably have had these drugs for the previous surgery in the form of morphine or “morphine-like” drugs given via the intravenous drip or a tablet taken by mouth. The side effects of these drugs include: • Slowing of bowel function • Sleepiness • Slowed breathing • Nausea and vomiting • Decreased appetite This study is not designed to test if medical cannabis is an effective pain management option, but rather seeks to assess if the drug can be safely administered and can be tolerated by patients having surgery such as your procedure and measure blood levels of cannabis chemicals.
Interventions
Vaporised Bedrobinol Product commenced day 1 post-operatively
Dose level 1 day 1 2.5mg THC flos vaporsied 4 times per day
Dose level 2 day 2 5mg THC flos vaporised 4 times per day if no dose-limiting toxicity greater than grade 2 adverse event
Dose level 3 day 3 10mg THC flos vaporsied 4 times per day if no dose-limiting toxicity greater than grade 2 adverse event.
No further dose after day 3.
Sponsors
Hunter New England Local Health District
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged 18 years or older - Signed written informed consent - Undergoing reversal of ileostomy at participating hospital - Willing and able to comply with all study requirements, including treatment, timing and assessments including blood tests, and, - Undertaking by participant both male and female of child bearing potential to take reliable contraceptive precautions for the duration of therapy and for three months after discontinuation of therapy.
Exclusion criteria
Patients from the above group will be excluded if they: - Are pregnant, lactating, or using inadequate contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to study participation. Men must have been surgically sterilised or use a (double if required) barrier method of contraception. - Have severe renal impairment - Unstable cardiovascular disease (uncontrolled hypertension, unstable ischaemic heart disease, - History of epilepsy or recurrent seizures - History of schizophrenia, other psychotic illness, severe personality disorder, suicidal ideation, or other significant psychiatric disorder, other than depression associated with underlying condition - Substance use disorder to alcohol, opioids, benzodiazepines, or illicit stimulants - Concomitant treatment with any potent CYP3A4 inhibitors such as ketoconazole, macrolides - Is scheduled to receive any other investigational drug during the present study - Prior hypersensitivity or intolerable adverse reaction to cannabis or cannabinoid based medications, 5HT3 antagonist, dexamethasone, NK1 antagonist - have a known allergy or adverse drug reaction to cannabinoids and its excipients - remain intubated post-procedure
Outcome results
None listed