Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Condition: Cannabis Use Disorder
MeSH terms: Marijuana Abuse
Intervention: Cannabidiol; Placebo
Intervention description: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.; Participants will receive placebo over a 6-week treatment period.
Intervention MeSH terms: Cannabidiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cannabidiol

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.
    

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)