- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03102918
Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)
August 21, 2018 updated by: Kevin P. Hill, MD, MHS, Mclean Hospital
Investigators aim to determine Epidiolex's promise as a pharmacotherapy for cannabis use disorder.
Investigators hypothesize that Epidiolex, when added to medical management, will result in greater reductions in marijuana use compared to placebo as measured by the 2 primary outcome measures: 1) quantitative THC levels and 2) self-report by Timeline Follow Back.
Secondary outcome measures will include treatment retention, patient satisfaction, cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, , compliance, and cigarette use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to begin to evaluate Epidiolex as a pharmacotherapy for adults with cannabis use disorder.
In this randomized, double-blind, placebo-controlled trial, cannabis-dependent subjects ages 18-65 will receive medical management over a 6-week period, with half receiving Epidiolex treatment and half receiving placebo.
Participants will receive either up to 800 mg Epidiolex or placebo over a 6-week treatment period.
Following treatment completion, participants will have a follow-up visits at 10 and 14 weeks.
Primary outcomes will include self-report of cannabis smoking and results of quantitative urine drug screens for cannabis.
Secondary outcome measures will include treatment retention, patient satisfaction, cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, compliance, and cigarette use.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Belmont, Massachusetts, United States, 02478
- McLean Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range 18-65 years
- DSM 5 diagnosis of cannabis use disorder, based on the Structured Clinical Interview for DSM 5 (SCID-5)
- Express a desire to quit cannabis use within the next 30 days
- Have used cannabis on ≥4 days within the past 30 days (i.e., an average of ≥1 day per week)
- For women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and monthly pregnancy tests; for men, contraception will be discussed at the beginning of the study with the study physician
- Consent for us to communicate with their prescribing clinician
- Furnish the names of 2 locators, who would assist study staff in locating them during the study period
- Live close enough to McLean Hospital to attend study visits
- Plan to stay in the Boston area for the next 3 months
- Are willing and able to sign informed consent
Exclusion Criteria:
- Current diagnosis of other drug or alcohol dependence (excluding nicotine)
- Recent (within 3 months) significant cardiac disease
- Current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder
- Current medical condition (including significant laboratory abnormalities, such as abnormal liver function tests) that could prevent regular study attendance
- Mental retardation or organic mental disorder
- Acutely dangerous or suicidal behavior
- Currently in a residential treatment setting in which substance use is monitored and restricted, since the restricted access to drugs could represent an important confounding variable
- Pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the investigator to be effective
- Concomitant daily treatment with opioid analgesics, sedative hypnotics, or other known CNS depressants
- Known hypersensitivity to cannabinoids or sesame oil
- Disease of the gastrointestinal system, liver, or kidneys that may impede metabolism or excretion of CBD
- Inability to read or write in English
- History of seizures, head trauma or other history of CNS insult that could predispose the subject to seizures
- Currently taking valproic acid, lamotrigine, or propranolol, medication metabolized by UGT1A9 or UGT2B7 enzymes (CBD may affect these UGT levels)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Participants will receive placebo over a 6-week treatment period.
|
ACTIVE_COMPARATOR: Cannabidiol
Epidiolex
|
Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-report Instruments to Measure Cannabis Use
Time Frame: During Week 6
|
Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback
|
During Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 20, 2016
Primary Completion (ACTUAL)
August 30, 2017
Study Completion (ACTUAL)
August 30, 2017
Study Registration Dates
First Submitted
March 31, 2017
First Submitted That Met QC Criteria
March 31, 2017
First Posted (ACTUAL)
April 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 25, 2019
Last Update Submitted That Met QC Criteria
August 21, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P002013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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