An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tonix Pharmaceuticals, Inc.

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).