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:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT01747850
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female (gender to be analyzed as a covariate)
* Understand and willing to comply with study requirements and restrictions
* Willing to use appropriate contraceptive method throughout the study
* Otherwise healthy as judged by investigator based on medical history, physical exam, vitals, ECG and labs
* DSM-IV criteria for current marijuana dependence
* Report marijuana as primary drug of abuse
* Report using marijuana at least 5 days a week for at least one month
* Have marijuana positive urine drug screen
* Treatment seeking cannabis smoker
* Smoke less than or equal to the equivalent of 4 joints per day (or four grams per day if participants smokes cannabis in other forms)
Exclusion Criteria:
* Meets DSM-IV criteria for a current axis I disorder including substance use disorder other than cannabis, nicotine or caffeine dependence.
* First-degree relative with schizophrenia
* History of seizures
* History of cardiovascular disease
* History of pulmonary disease such as asthma, COPD
* Clinically significant pathology in oral cavity and poor oral hygiene
* Known sensitivity to dronabinol, cannabidiol, propylene glycole, ethanol or peppermint oil (used in SATIVEX® buccal spray)
* Unstable medical conditions
* Pregnant or breast-feeding
* Currently taking psychotropic medication with benefit for any other illness than treatment of insomnia,
* Holding a job that involves driving, operating heavy machines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01747850
Study Brief:
Protocol Section:
NCT01747850