Cannabidiol: a Novel Intervention for Cannabis Use Problems?

University College London (UCL)

Status and phase: Completed; Phase 2

Conditions: Cannabis Use Disorder

Treatments: Drug: Placebo; Drug: Cannabidiol

Study type: Interventional

Funder types: Other

Identifiers

NCT02044809

12/0278

Details and patient eligibility

About

The purpose of this trial is to investigate a novel treatment for cannabis dependence: cannabidiol. Between 96 and 168 young people who want to quit cannabis and meet criteria for moderate cannabis use disorder (DSM-5) will be recruited from the community. Stage one aims to identify the Most Effective Dose (MEDmg) of oral cannabidiol for reducing cannabis use over four treatment weeks. Stage two will determine whether the MED identified in stage 1 can offer an effective treatment for cannabis dependence.

Enrollment: 82 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 16 and 60 years old.
• Meet DSM-5 criteria for moderate cannabis use disorder (≥4 DSM-5 criteria)
• Express desire to quit using cannabis within the next four weeks,
• Have ≥1 previous failed quit attempt.
• Smoke tobacco with cannabis,
• Test positive for recent cannabis use according to urine analysis,
• Vital signs within healthy limits and have capacity to give consent

Exclusion criteria

• Not willing to use effective contraception from when consent is taken to 6 weeks after treatment has stopped
• Positive pregnancy test or breastfeeding
• Allergies to the Investigational Medicinal Product (IMP) or placebo and its excipients
• >twice/month use of other illicit drugs
• Outside normal Body Mass Index (BMI)
• A physical health problem deemed clinically significant
• The use of current prescribed psychotropic drugs
• Current or prior self-reported diagnosis of a psychotic disorder
• Non-English speakers due to verbal assessments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Cannabidiol 200mg Oral

Experimental group

Treatment:

Drug: Cannabidiol

Cannabidiol 400mg Oral

Experimental group

Treatment:

Drug: Cannabidiol

Cannabidiol 800mg Oral

Experimental group

Treatment:

Drug: Cannabidiol