Observational Study of the Safety, Tolerability and Efficacy of Cannabidiol Oro-buccal Sprays for Treating Pain and/or Stress

Not Applicable

• Conditions: Chronic pain or pain associated with chronic conditions appropriate for management with cannabidiol; Stress conditions appropriate for management with cannabidiol; Mental Health - Other mental health disorders; Anaesthesiology - Pain management

• Registration Number: ACTRN12622001137785
• Lead Sponsor: Medlab Clinical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-17
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1.Patients who have been prescribed MC-1020 or MC-1023 for pain and/or stress.
2.Prospective participants greater than or equal to 18 years of age at the time of entry on study;
3.Prospective participants have the cognitive ability to understand the informed consent process and to give informed consent to participate in the observational study;
4.Prospective participants are eligible to be lawfully prescribed MC-1020 or MC-1023 by the Participating Doctor;
5.Prospective participants are able to visit their Participating Doctor’s and Participating Pharmacist’s clinics as required while being treated MC-1020 or MC-1023 and are able to provide information as required for the duration of the study;
6.Prospective participants agree to abstain from using any cannabis products other than MC-1020 or MC-1023 for the duration of their participation in the study.

Exclusion Criteria

1.Prospective participants will be ineligible if they are under the age of 18 years;
2.Prospective participants will be ineligible if they are unwilling or unable to sign the Informed Consent Forms or cannot understand the Participant Information Sheet provided;
3.Prospective participants will be ineligible if they have a hypersensitivity to cannabinoids or to any of the study treatment excipients;
4.Pregnant or lactating women;
5.Prospective participants judged by the Principal Investigator to be ineligible for participation as study participants for any reason;
6.Prospective participants will be ineligible if they are unwilling or unable to perform study procedures as described in the study protocol.
7.Prospective participants will be ineligible if they have concurrent medicinal or recreational cannabinoid use.

Study & Design

• Study Type: Observational
• Study Design: Not specified