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 2

Withdrawn

• Conditions: Cocaine Intoxication
• Interventions: Other: Usual Care; Drug: TNX-1300

• Registration Number: NCT04996056
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-09
• Study Start: 2021-09-03
• Status Verified: 2022-06
• Primary Completion: 2022-06-16
• Study Completion: 2022-06-16
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Usual Care per the Emergency Department protocol for treating Cocaine Intoxication
TNX-1300	TNX-1300	TNX-1300 Intravenous injection 200 mg once over 2 mins

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions	Baseline to 12 Hours	Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions

Secondary Outcome Measures

Name	Time	Method
Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)	Baseline to 6 Hours	Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)
Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline	Baseline to 6 Hours	Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline

Trial Locations

Locations (2)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States