Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder (CBD)
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ClinicalTrials.gov Identifier: NCT03102918 |
Recruitment Status :
Completed
First Posted : April 6, 2017
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cannabis Use Disorder | Drug: Cannabidiol Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
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. |
Primary Purpose: | Treatment |
Official Title: | Cannabidiol Pharmacotherapy for Adults With Cannabis Use Disorder |
Actual Study Start Date : | February 20, 2016 |
Actual Primary Completion Date : | August 30, 2017 |
Actual Study Completion Date : | August 30, 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Cannabidiol
Epidiolex
|
Drug: Cannabidiol
Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
Other Name: Epidiolex |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Participants will receive placebo over a 6-week treatment period. |
- Self-report Instruments to Measure Cannabis Use [ Time Frame: During Week 6 ]Self-reported cannabis inhalations per day during Week 6 as reported by Timeline Followback

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102918
United States, Massachusetts | |
McLean Hospital | |
Belmont, Massachusetts, United States, 02478 |
Documents provided by Kevin P. Hill, MD, MHS, Mclean Hospital:
Responsible Party: | Kevin P. Hill, MD, MHS, Assistant Professor of Psychiatry, Mclean Hospital |
ClinicalTrials.gov Identifier: | NCT03102918 |
Other Study ID Numbers: |
2015P002013 |
First Posted: | April 6, 2017 Key Record Dates |
Results First Posted: | January 25, 2019 |
Last Update Posted: | January 25, 2019 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cannabidiol |
Marijuana Abuse Substance-Related Disorders Chemically-Induced Disorders |
Mental Disorders Cannabidiol Anticonvulsants |