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Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)

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ClinicalTrials.gov Identifier: NCT03102918
Recruitment Status : Completed
First Posted : April 6, 2017
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Tracking Information
First Submitted Date  ICMJE March 31, 2017
First Posted Date  ICMJE April 6, 2017
Results First Submitted Date  ICMJE August 21, 2018
Results First Posted Date  ICMJE January 25, 2019
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE February 20, 2016
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 31, 2017)
  • self-report of cannabis smoking [ Time Frame: 6 weeks ]
  • Quantitative urine drug screens for cannabis [ Time Frame: 6 weeks ]
Change History Complete list of historical versions of study NCT03102918 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Official Title  ICMJE Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Cannabis Use Disorder
Intervention  ICMJE
  • Drug: Cannabidiol
    Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
    Other Name: Epidiolex
  • Drug: Placebo
    Participants will receive placebo over a 6-week treatment period.
Study Arms  ICMJE
  • Active Comparator: Cannabidiol
    Epidiolex
    Intervention: Drug: Cannabidiol
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2017)
60
Actual Study Completion Date  ICMJE August 30, 2017
Actual Primary Completion Date August 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03102918
Other Study ID Numbers  ICMJE 2015P002013
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kevin P. Hill, MD, MHS, Mclean Hospital
Study Sponsor  ICMJE Mclean Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mclean Hospital
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP