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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02559167
Eligibility Criteria:
Inclusion criteria
* DSM-5 criteria for current cocaine use disorder (moderate or severe).
* Current cocaine use with last use during two weeks prior to admission to the study as confirmed by the Timeline Follow Back questionnaire.
* Age between 18 and 65 years old (inclusive).
* Women with diagnosed menopause (as confirmed by the study physician), under the age of 65, will be eligible for the study
* Subject consents to inpatient detoxification at the CHUM.
* Ability to give valid, informed consent.
* Ability to speak and read French or English.
Exclusion criteria
* Severe and/or unstable hepatic, neurologic (including diagnosis of seizures), cardiac (including arrhythmias) or renal disease), or any other severe or unstable medical condition that precludes safe participation in the study according to the study physician.
* Patients who are already immunocompromised (e.g., patients with human immunodeficiency virus-1 who do not meet the following criteria: undetectable HIV virus (using modern assay) and CD4 count \>350 cells/uL in the last 6 months prior to enrolment, patients on antiretroviral therapy; or other infectious organisms), exhibit malignancy and/or have autoimmune syndromes.
* Hypersensitivity to cannabinoids or any of the excipients of the investigational medicinal products.
* Severe psychiatric condition (history of schizophrenia, schizoaffective disorder or bipolar disorder); current acute psychosis, mania or severe suicidality based on the Mini International Neuropsychiatric Interview (MINI 7.0)).
* Pregnancy or breastfeeding.
* Inability (or unwillingness) of women of childbearing potential to use a medically acceptable form of contraception throughout study duration and for 3 months after dosing stops. A medically acceptable form of contraception is either: (1) contraceptive pill or intrauterine device or depot hormonal preparation (ring, injection, implant); and/or (2) a double barrier method of contraception such as diaphragm, sponge with spermicide and condom.
* Couples planning to conceive within the next 12 months.
* Men with history of fertility problems.
* Another current severe substance use disorder or any substance use disorder that would require pharmacological treatment according to the addiction specialist except nicotine (e.g. benzodiazepine or opiate for alcohol or opioid use disorder).
* Current treatment with medications that may interact with Cannabidiol (i.e., psychotropic medications such as benzodiazepines or anticonvulsants) or anticipation that the patient may need to initiate such treatment during the study.
* Any serious medical condition or psychiatric illness that precludes the subject from signing the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02559167
Study Brief:
Protocol Section:
NCT02559167