Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03102918
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03102918
Study Brief:
Protocol Section:
NCT03102918