Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)

• 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: Mclean Hospital
• Information provided by (Responsible Party): Kevin P. Hill, MD, MHS, Mclean Hospital

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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 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
• Actual Primary Completion Date: August 30, 2017
• Actual Study Completion Date: August 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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

Eligibility Criteria

• 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)

Contacts and Locations

Locations

United States, Massachusetts

McLean Hospital

Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

Mclean Hospital

  Study Documents (Full-Text)

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

Study Protocol and Statistical Analysis Plan  [PDF] March 1, 2017

More Information

• Responsible Party: Kevin P. Hill, MD, MHS, Assistant Professor of Psychiatry, Mclean Hospital
• ClinicalTrials.gov Identifier: NCT03102918
• Other Study ID Numbers: 2015P002013
• First Posted: April 6, 2017
• Results First Posted: January 25, 2019
• Last Update Posted: January 25, 2019
• Last Verified: August 2018

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:

Marijuana Abuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Epidiolex; Anticonvulsants