Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study

The University of New South Wales (Other)
Overall Status
Unknown status ID

Study Details

Study Description

Brief Summary

Single subject repeated measures design of an open label administration of Cannabidiol (CBD) to 5 participants withdrawing from cannabis use in an inpatient setting. 300mg of CBD will be administered once on day 1, twice on days 2-5 and once on day 6. Participants will be discharged on day 7. CBD will be administered orally in capsules.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
5 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: CBD

Open label CBD

Drug: CBD
Other Names:
  • No brand names as cannabidiol is not commercially available
  • Outcome Measures

    Primary Outcome Measures

    1. Severity of cannabis withdrawal [7 days]

      Reduction of number and severity of withdrawal symptoms including insomnia, anxiety, agitation, restlessness, low mood. This will be assessed using the only validated scale: The Cannabis Withdrawal Scale

    2. Safety of CBD for cannabis withdrawal [7 days]

      Unwanted effects of any nature will be monitored using the reporting protocols employed in similar studies and monitored by senior addiction specialists. Any SAEs will be reported to the TGA as required.

    Secondary Outcome Measures

    1. Treatment retention [7 days]

      Retention in inpatient treatment will be assessed against previous studies of cannabis treatment retention and TAU participants in the unit

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:

    Inclusion Criteria: Participants must be seeking treatment for cannabis use disorder and report having experienced cannabis withdrawal symptoms in past quit attempts (as defined by participants' experiencing 3 or more symptoms after cessation of prolonged cannabis use or continuing use to avoid withdrawal symptoms). They must meet the criteria for a DSMV current cannabis use disorder and test positive to THC on urinary dip stick test on admission. They must be aged 18-65 and speak English.

    Exclusion Criteria: The aim is to exclude individuals with concurrent conditions that jeopardise patient safety or confound study data interpretation. These include (a) presence of another substance use disorder, operationalized as (i) more than twice weekly use of an illicit drug in the last 90 days (other than cannabis), (ii) alcohol AUDIT scores of greater than 15, or a current history of alcohol dependence, (iii) substance use treatment in the last 30 days, or (iv) current prescription drug abuse or dependence (benzodiazepines, opioids or psychostimulants); (b) evidence of unstable or severe medical conditions or cognitive or psychiatric impairment (including developmental disorder, schizophrenia or other psychotic disorders) that may prevent participation; (f) known or suspected allergy to propylene glycol, corn oil; (h) women of child bearing age not on a reliable contraceptive or men intending to start a family with one month of trial participation; (i) pregnant or lactating women; (j) not available for follow-up; (k) no access to telephone; or (l) unwillingness to provide written confirmation that they have been informed about, and will comply with, exclusion from driving when receiving medication. Only persons meeting all criteria will be assessed by trial medical officers and research staff as appropriate.

    Contacts and Locations


    No locations specified.

    Sponsors and Collaborators

    • The University of New South Wales


    • Principal Investigator: Martin Weltman, PhD MD, Nepean Blue Mountains Local Health District

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Jan Copeland, Professor/Director NCPIC, The University of New South Wales Identifier:
    Other Study ID Numbers:
    • NCPIC2014001
    First Posted:
    Mar 11, 2014
    Last Update Posted:
    Mar 11, 2014
    Last Verified:
    Mar 1, 2014
    Keywords provided by Jan Copeland, Professor/Director NCPIC, The University of New South Wales
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 11, 2014