None listed
Conditions
Brief summary
The primary objectives of the study is to examine the feasibility, safety and efficacy of cannabidiol (CBD) in the management of concurrent mood and cannabis use disorders in young people, in a randomized controlled study. Specifically, the study will assess recruitment rates, retention rates, adverse events, the quantity and frequency of cannabis use, and the impact of CBD on patient mental health outcomes and well-being. Current treatments for anxiety and depression are of limited efficacy in a considerable proportion of patients (30% of depressed patients are pharmacoresistant) and are associated with troublesome side effects that reduce compliance; the development of novel, improved therapeutic treatments would fill a considerable unmet medical need. CBD has emerged as one of the most promising candidates in treating psychiatric disorders. Research suggests that greater rates of mental health problems in cannabis users are related to increased use of high THC/low CBD varieties of cannabis. In various animal and human laboratory and clinical studies, CBD has been found to reduce the intoxicating and psychotomimetic effects of THC, while CBD given alone has also been found to relieve anxiety and nausea and to have anti-inflammatory and antipsychotic effects. Thirty participants (male and female) will be recruited over a period of 9 months. The study will be conducted in the Department of Addiction Medicine at St Vincent's Hospital Melbourne. Participants will complete an initial assessment as per normal clinical practice. Eligible participants will be contacted to attend a baseline assessment and informed consent.. Participants will be randomized into either a CBD or placebo treatment group for a period of 12 weeks with follow-up at 14 weeks. All participants will be offered up to 6 sessions of manualised psychotherapy as per standard clinical practice.
Interventions
This is a double blind placebo controlled RCT consisting of two groups. An intervention and a control group.
The intervention group will receive 800mg of CBD will be administered in 200mg capsules. Participants will be required to take 400mg (i.e. 2 capsules) of CBD twice a day (morning and night) approximately 12 hours apart for a 12 week treatment period. The active ingredient is fully synthetic (99.6% Cannabidiol powder dissolved in corn oil encapsulated in gelatine). It is the equivalent iso
This is a double blind placebo controlled RCT consisting of two groups. An intervention and a control group. The intervention group will receive 800mg of CBD will be administered in 200mg capsules. Participants will be required to take 400mg (i.e. 2 capsules) of CBD twice a day (morning and night) approximately 12 hours apart for a 12 week treatment period. The active ingredient is fully synthetic (99.6% Cannabidiol powder dissolved in corn oil encapsulated in gelatine). It is the equivalent isomer of naturally occurring Cannabidiol. The active ingredient is produced at BioSynthesis Pharma Group FDA and MHRA approved facility in the UK. The matching placebo will be administered in capsules with same appearance and taste and participants will be required to take of the same number of capsules twice daily as participants in the active arm. All medications received and dispensed as part of this trial will be inventoried and accounted for throughout the trial on the Investigation Agent Accountability Record (study medication log) by the clinical trials pharmacists. The medication will be dispensed weekly for the first month, and then monthly after that. Patient compliance will be assessed through pill counts when participants return to receive their next lot of medication, as well as through self-report measures and the level of CBD in urine from samples collected at baseline, week 2, week 6 and week 12. At the completion of each participant’s treatment period, any unused medications will be returned to the trial pharmacist, documented, and then subsequently destroyed. All participants will be provided with six 30-50 minute sessions of manualized therapy based on the Ready 2 Change program developed by Turning Point, Eastern Health. This is a semi-structured program involving one-on-one sessions with a trained addictions counsellor. The first two sessions are held weekly, and follow up sessions may be weekly or fortnightly thereafter. After the 12 week intervention period (or if any participant meets exit or withdrawal criteria), treatment as usual will be provided by Department of Addiction Medicine clinicians. For the purposes of the study analyses, ‘entry’ will be considered to be the date the participant commences the study medication.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 28 Years
Healthy volunteers
No
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.
Outcome results
None listed