Phase 1
N=10
Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder
Cannabis Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03102918 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Self-report Instruments to Measure Cannabis Use — 26.72; 5.256 Inhalations of Cannabis Per Day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Cannabidiol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-report Instruments to Measure Cannabis Use |
26.72; 5.256 | — |
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)
Data sourced from ClinicalTrials.gov (NCT03102918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.