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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT03978156
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age ≥18 years, able to understand and sign the informed consent form
* Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
* Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
* Willing to abstain from marijuana, medical and illicit, during study weeks 1 through 6.
* For patients currently receiving hydroxyurea and/or L-glutamine, on a stable dose(s) for at least 3 months
* For patients currently on a chronic red blood cell transfusion program, on such a program for at least 3 months
Exclusion Criteria:
* Known intolerance to dronabinol, sesame oil, or marijuana
* Patients with a diagnosis or medical history of any psychiatric disorder with psychosis
* Presence of any concomitant medical condition, or use of concomitant medication, that, in the Investigator's opinion, may place the subject at increased risk of side effects of dronabinol.
* Pregnant or nursing women
* If a woman capable of becoming pregnant, unwilling to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception or vaginal ring, medroxyprogesterone, contraceptive implants, intrauterine device, or patch, surgical sterilization, total abstinence. We have not included a similar restriction for men as the current FDA approval includes no such restriction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03978156
Study Brief:
Protocol Section:
NCT03978156