A Randomised Controlled Trial of Cannabidiol (CBD) for the treatment of Cannabis Use Disorder (CUD)

Phase 3

Recruiting

• Conditions: Cannabis use disorder; Drug addiction; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Mental Health - Addiction

• Registration Number: ACTRN12623000526673
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-19
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Aged 18 to 65 years.
2. Meeting DSM-5 criteria for moderate or severe Cannabis Use Disorder (more than or equal to 4 out of 11 criteria), with recent frequent cannabis use (more than or equal to 4 days per week in the preceding 4 weeks).
3. Willing and able to provide informed consent to study procedures.
4. Proficient in English at a conversational level sufficient to participate in counselling intervention (assessed by Study Medical Officer (SMO) at medical assessment).

Exclusion Criteria

1. Prescribed medicinal cannabis products (e.g., CBD, THC) for any indication in the previous 4 weeks.
2. Another active (past year) moderate-severe substance use disorder other than tobacco; operationalised on clinical assessment by SMO using DSM5 criteria.
3. Active or severe medical (e.g., pain, epilepsy, cardiovascular disease) or psychiatric conditions (e.g., psychosis, severe affective disorder) as identified by the Study Medical Officer; moderate to severe hepatic disease (transaminase elevations more than 3 times, bilirubin more than 2 times upper normal limits).
4. Pregnant or lactating women (urine beta-hCG).
5. Hypersensitivity to CBD or excipients of Epidyolex.
6.Using medications with known drug-drug hepatic CYP-450 interactions with CBD: 3A4, (e.g., carbamazepine, fluvoxamine, methadone), 2C19 (e.g., rifampin); CYP2B6 (e.g., bupropion), CYP2C9 (e.g., warfarin). The potential range of drug-drug interactions are considerable, and the SMO will make an assessment whether the potential for DDI is clinically significant (e.g., as for medications such as warfarin, HIV or anticonvulsant medications), and the SMO can discuss with PI Lintzeris if uncertain.
7. Not available for follow-up (e.g., travel, impending imprisonment).
8. Court-mandated treatment requiring abstinence from drugs.
9. Current active treatment for cannabis use disorder. People in existing treatment counselling and/or medication-based treatment for their cannabis use disorders (e.g., Alcohol and Other Drug services, private health services) are not eligible for the trial at the time of application. To participate, clients would have to choose to cease their existing treatment (counselling, medication) for a 4-week period prior to being formally assessed for the trial.
10. Received an investigational medicinal product within the last 4 weeks (or 5 half-lives if using long-acting investigational drugs).

Study & Design

• Study Type: Interventional
• Study Design: Not specified