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

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ClinicalTrials.gov Identifier: NCT02083874
Recruitment Status : Unknown
Verified March 2014 by Jan Copeland, The University of New South Wales.
Recruitment status was:  Active, not recruiting
First Posted : March 11, 2014
Last Update Posted : March 11, 2014
Sponsor:
Information provided by (Responsible Party):
Jan Copeland, The University of New South Wales

Tracking Information
First Submitted Date  ICMJE March 6, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date March 11, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
  • Severity of cannabis withdrawal [ Time Frame: 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
  • Safety of CBD for cannabis withdrawal [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2014)
Treatment retention [ Time Frame: 7 days ]
Retention in inpatient treatment will be assessed against previous studies of cannabis treatment retention and TAU participants in the unit
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
Official Title  ICMJE Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cannabis Use Disorder
Intervention  ICMJE Drug: CBD
Other Name: No brand names as cannabidiol is not commercially available
Study Arms  ICMJE Experimental: CBD
Open label CBD
Intervention: Drug: CBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 10, 2014)
5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083874
Other Study ID Numbers  ICMJE NCPIC2014001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jan Copeland, The University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Weltman, PhD MD Nepean Blue Mountains Local Health District
PRS Account The University of New South Wales
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP