Cannabidiol: a Novel Intervention for Cannabis Use Problems?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-06-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Cannabis Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Cannabidiol 200mg Oral

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol 400mg Oral

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Cannabidiol 800mg Oral

Group Type EXPERIMENTAL

Cannabidiol

Intervention Type DRUG

Interventions

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Cannabidiol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No