Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder

• Status: Completed
• Trial end date: 2017-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mclean Hospital
• Treatments: Cannabidiol

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)