Cannabis Use Disorder
Conditions
Keywords
Cannabidiol
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.
Detailed description
Investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to begin to evaluate Epidiolex as a pharmacotherapy for adults with cannabis use disorder. 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. Participants will receive either up to 800 mg Epidiolex or placebo over a 6-week treatment period. Following treatment completion, participants will have a follow-up visits at 10 and 14 weeks. Primary outcomes will include self-report of cannabis smoking and results of quantitative urine drug screens for cannabis. Secondary outcome measures will include treatment retention, patient satisfaction, cannabis withdrawal, cannabis craving, depressive symptoms, anxiety symptoms, compliance, and cigarette use.
Interventions
DRUGCannabidiol
Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
DRUGPlacebo
Participants will receive placebo over a 6-week treatment period.
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
This is a double-blind study.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-report Instruments to Measure Cannabis Use | During Week 6 | Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cannabidiol Epidiolex
Cannabidiol: Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period. | 5 |
| Placebo Placebo
Placebo: Participants will receive placebo over a 6-week treatment period. | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Cannabidiol | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 33.6 years STANDARD_DEVIATION 10.7 | 30.8 years STANDARD_DEVIATION 11.3 | 28.0 years STANDARD_DEVIATION 12.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 8 Participants | 5 Participants |
| Self-report Cannabis Use during Baseline | 26.03 Inhalations per day STANDARD_DEVIATION 22.03 | 23.53 Inhalations per day STANDARD_DEVIATION 23.18 | 21.03 Inhalations per day STANDARD_DEVIATION 26.61 |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Self-report Instruments to Measure Cannabis Use
Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback
Time frame: During Week 6
Population: One subject in the Cannabidiol arm was withdrawn from the study before Week 6 due to poor medication adherence.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cannabidiol | Self-report Instruments to Measure Cannabis Use | 26.72 Inhalations of Cannabis Per Day | Standard Deviation 26.96 |
| Placebo | Self-report Instruments to Measure Cannabis Use | 5.256 Inhalations of Cannabis Per Day | Standard Deviation 4.34 |