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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT04996056
Eligibility Criteria:
Inclusion Criteria:
1. Subject is male (sex assigned at birth).
2. Subject is 18-50 years of age.
3. Subject has the capacity to provide voluntary written informed consent.
4. At Screening, subject presents with a SIS total score of ≥6 and a score \>1 on at least 1 of the 3 cardiovascular items (HR, systolic and diastolic BP).
5. At Screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms.
6. Subject has a positive urine drug screen test at Screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids or opiates).
7. Subject is a suitable candidate for investigational treatment based on the opinion of the investigator.
Exclusion Criteria:
1. Subject who has been admitted to the ED involuntarily.
2. Subject who participated in this clinical study previously.
3. Subject received naloxone (Narcan) within 3 hours prior to informed consent.
4. Subject tests positive for 3,4-Methylenedioxymethamphetamine (MDMA) or amphetamine at Screening.
5. Subject has a prior or current clinically significant untreated cardiac condition. Untreated hypertension may be allowed if not considered severe or life threatening.
6. Subject incurred or is likely to incur a myocardial infarction or other life-threatening severe event or has acute ECG changes indicative of acute coronary syndrome according to investigator judgment.
7. Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of clinical outcome parameters.
8. Subject requires physical restraints due to physiological and/or behavioral symptoms.
9. Participation in another investigational drug study (current or within 30 days of Screening).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04996056
Study Brief:
Protocol Section:
NCT04996056