NCT02083874

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 11, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

March 6, 2014

Last Update Submit

March 10, 2014

Conditions

Cannabis Use Disorder

Keywords

cannabidiolCBDmarijuanawithdrawaltreatment

Outcome Measures

Primary Outcomes (2)

  • 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

    7 days

  • 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.

    7 days

Secondary Outcomes (1)

  • Treatment retention

    7 days

Study Arms (1)

CBD

EXPERIMENTAL

Open label CBD

Drug: CBD

Interventions

CBDDRUG
Also known as: No brand names as cannabidiol is not commercially available
CBD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Martin Weltman, PhD MD

    Nepean Blue Mountains Local Health District

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor/Director NCPIC

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 11, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

March 11, 2014

Record last verified: 2014-03