Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

Completed · Phase 1 · Has a placebo group

Conditions studied: Cannabis Use Disorder

In brief

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.

Key facts

Study ID

NCT03102918

Run by

Mclean Hospital

People needed

10

Starts

2016-02-20

Expected to finish

2017-08-30

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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)

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States

Full record on ClinicalTrials.gov

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