Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

NCT03102918 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2015P002013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use Disorder

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (1)

• Self-report Instruments to Measure Cannabis Use

  Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback

  During Week 6

Study Arms (2)

Cannabidiol

ACTIVE COMPARATOR

Epidiolex

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cannabidiol DRUG

Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.

Also known as: Epidiolex

Cannabidiol

Placebo DRUG

Participants will receive placebo over a 6-week treatment period.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Due to the small sample size, more subjects would need to be included to be able to draw definitive conclusions from this study.

Results Point of Contact

• Title: Dr. Kevin Hill
• Organization: Beth Israel Deaconess Medical Center

khill1@bidmc.harvard.edu

617-667-1504

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: February 20, 2016
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: January 25, 2019
• Results First Posted: January 25, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)