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Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)

Primary Purpose

Cannabis Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
Mclean Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Use Disorder focused on measuring Cannabidiol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • McLean Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Cannabidiol

Placebo

Arm Description

Epidiolex

Placebo

Outcomes

Primary Outcome Measures

Self-report Instruments to Measure Cannabis Use
Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback

Secondary Outcome Measures

Full Information

First Posted
March 31, 2017
Last Updated
August 21, 2018
Sponsor
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03102918
Brief Title
Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Acronym
CBD
Official Title
Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 20, 2016 (Actual)
Primary Completion Date
August 30, 2017 (Actual)
Study Completion Date
August 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use Disorder
Keywords
Cannabidiol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
This is a double-blind study.
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cannabidiol
Arm Type
Active Comparator
Arm Description
Epidiolex
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
Epidiolex
Intervention Description
Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive placebo over a 6-week treatment period.
Primary Outcome Measure Information:
Title
Self-report Instruments to Measure Cannabis Use
Description
Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback
Time Frame
During Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

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