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

NCT ID: NCT02083874

Last Updated: 2014-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Cannabis Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBD

Open label CBD

Group Type: EXPERIMENTAL

CBD

Intervention Type: DRUG

Interventions

CBD

Intervention Type: DRUG

Other Intervention Names

No brand names as cannabidiol is not commercially available

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Jan Copeland

Professor/Director NCPIC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Weltman, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Nepean Blue Mountains Local Health District

Other Identifiers

NCPIC2014001

Identifier Type: -

Identifier Source: org_study_id