Cannabiol (CBD) for Cannabis and Mood Disorders in Young Adults (CCAMDYA)

Phase 2

Recruiting

• Conditions: Mood disorders; Cannabis use; Mental Health - Depression; Mental Health - Addiction

• Registration Number: ACTRN12616001001482
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-28
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

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

Inclusion Criteria

•At least greater than or equal to 18 years of age & less than 28 years of age at presentation.
•Moderate to severe DSM 5 Cannabis Use Disorder
•Cannabis use on average at least greater than or equal to 3 days per week (over last 28 days).
•Desire to reduce or cease cannabis use
•Moderate to severe depression, indicated by a score greater than or equal to 11 and less than or equal to 20 on the QIDS-C at first contact with the service.
•A diagnosis of a mood disorder with or without psychotic features at baseline using a structured clinical interview.
•Fluent in English.
•Able to give informed consent.
•Agree to participate in all tests, including urine and saliva drug screens.
•Prepared to take trial medications as requested.

Exclusion Criteria

•More than fortnightly use of an illicit drug in the last 28 days (other than cannabis).
•Dependence on a substance other than cannabis and tobacco.
•Acute suicidal behaviour.
•Evidence of severe medical condition (including, severe hepatic (LFTs more than 5 times normal) and/or renal impairment (estimated GFR <60) or cardiovascular disease (hx of congential heart disease), or cognitive impairment (documented evidence of neuropsychological impairment)).
•People with current prescriptions (within past month) for antipsychotic medications or tricyclic antidepressants.
•Known or suspected allergy to cannabinoids, propylene glycol, ethanol, peppermint oil, corn oil or gelatine.
•Females who are pregnant, lactating, or not using adequate contraception.
•Males who are not using adequate contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified