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An Open Label Observational Study of Safety and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications

An Open Label, Multicenter, Observational Study to Assess the Safety, Tolerability and Efficacy of a Pharmaceutical grade Cannabis Medicine (MediCabilis™-CBD extract Oil) in Patients undergoing Medicinal Cannabis Therapy for Different Indications

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000741987
Acronym
BODOLOS
Enrollment
479
Registered
2020-07-16
Start date
2020-07-29
Completion date
2021-09-30
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a multicenter, open label, longitudinal observational study aiming to assess the safety, tolerability and efficacy of MediCabilis™ when used at the prescribed dose by physicians for different indications using data reported by patients during treatment.

Interventions

Assess safety, tolerability and efficacy of medicinal cannabis (MediCabilis) being prescribed for any indication. This is a multi-site, observational cohort study, examining the effect of oral cannabidiol in participants receiving MediCabilis for their conditions. Most of the Cannabis Clinics, monitor a range of patient reported outcome and experience measures at defined intervals over the treatment period as part of routine care. This study is designed to collect patient data (demographic, med

Assess safety, tolerability and efficacy of medicinal cannabis (MediCabilis) being prescribed for any indication. This is a multi-site, observational cohort study, examining the effect of oral cannabidiol in participants receiving MediCabilis for their conditions. Most of the Cannabis Clinics, monitor a range of patient reported outcome and experience measures at defined intervals over the treatment period as part of routine care. This study is designed to collect patient data (demographic, medical history, diagnosis) and also a range of validated patient-reported outcome and experience measures for patients who have received MediCabilis. Patients will be observed for up to 12 months.

Sponsors

Bod Australia
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Participants will be any patient who has been prescribed MediCabilis through the Special Access Scheme B or by an authorised prescriber. Participants may be taking MediCabilis in any dose, form, duration and free quency, and for any condition. Patients of any gender who is equal or greater than 18 years may participate. Prospective patients that understand the informed consent process and to give informed consent to participate in the study. Diagnosis of their condition/disease confirmed by patient’s GP or specialist. Prospective participants agree to abstain from using illicit cannabis products for the duration of their participation in the study.

Exclusion criteria

Any severe cognitive, intellectual disability, medical or psychiatric condition that impairs the participant’s ability to provide informed consent. Patients who are using illicit forms of cannabis.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026