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

Primary Purpose

Cannabis Use Disorder

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CBD
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring cannabidiol, CBD, marijuana, withdrawal, treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CBD

    Arm Description

    Open label CBD

    Outcomes

    Primary Outcome Measures

    Severity of cannabis withdrawal
    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
    Safety of CBD for cannabis withdrawal
    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

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

    Full Information

    First Posted
    March 6, 2014
    Last Updated
    March 10, 2014
    Sponsor
    The University of New South Wales
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02083874
    Brief Title
    Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
    Official Title
    Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    September 2014 (Anticipated)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of New South Wales

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cannabis Use Disorder
    Keywords
    cannabidiol, CBD, marijuana, withdrawal, treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CBD
    Arm Type
    Experimental
    Arm Description
    Open label CBD
    Intervention Type
    Drug
    Intervention Name(s)
    CBD
    Other Intervention Name(s)
    No brand names as cannabidiol is not commercially available
    Primary Outcome Measure Information:
    Title
    Severity of cannabis withdrawal
    Description
    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
    Time Frame
    7 days
    Title
    Safety of CBD for cannabis withdrawal
    Description
    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.
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Treatment retention
    Description
    Retention in inpatient treatment will be assessed against previous studies of cannabis treatment retention and TAU participants in the unit
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin Weltman, PhD MD
    Organizational Affiliation
    Nepean Blue Mountains Local Health District
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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