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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

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
Cannabis Use Disorder Drug: CBD Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
Study Start Date : March 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: CBD
Open label CBD
Drug: CBD
Other Name: No brand names as cannabidiol is not commercially available




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083874


Sponsors and Collaborators
The University of New South Wales
Investigators
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Principal Investigator: Martin Weltman, PhD MD Nepean Blue Mountains Local Health District

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Responsible Party: Jan Copeland, Professor/Director NCPIC, The University of New South Wales
ClinicalTrials.gov Identifier: NCT02083874     History of Changes
Other Study ID Numbers: NCPIC2014001
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: March 11, 2014
Last Verified: March 2014
Keywords provided by Jan Copeland, The University of New South Wales:
cannabidiol
CBD
marijuana
withdrawal
treatment
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Epidiolex
Anticonvulsants