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Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)

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ClinicalTrials.gov Identifier: NCT03102918
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cannabis Use Disorder Drug: Cannabidiol Drug: Placebo Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: This is a double-blind study.
Primary Purpose: Treatment
Official Title: Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Actual Study Start Date : February 20, 2016
Estimated Primary Completion Date : January 20, 2018
Estimated Study Completion Date : January 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Active Comparator: Cannabidiol
Epidiolex
Drug: Cannabidiol
Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
Other Name: Epidiolex

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Participants will receive placebo over a 6-week treatment period.




Primary Outcome Measures :
  1. Self-report instruments to measure cannabis use [ Time Frame: 6 weeks ]
  2. Quantitative urine drug screens for cannabis [ Time Frame: 6 weeks ]


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:   Yes
Criteria

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)

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): NCT03102918


Contacts
Contact: Kevin Hill, MD khill@mclean.harvard.edu

Locations
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Matthew Palastro, BS    617-855-3498    MPALASTRO@PARTNERS.ORG   
Principal Investigator: Kevin P Hill, MD, MHS         
Sponsors and Collaborators
Mclean Hospital

Responsible Party: Kevin P. Hill, MD, MHS, Assistant Professor of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT03102918     History of Changes
Other Study ID Numbers: 2015P002013
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kevin P. Hill, MD, MHS, Mclean Hospital:
Cannabidiol

Additional relevant MeSH terms:
Disease
Marijuana Abuse
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders