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

NCT ID: NCT04996056

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2022-06-16

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

Conditions

Cocaine Intoxication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TNX-1300

TNX-1300 Intravenous injection 200 mg once over 2 mins

Group Type: EXPERIMENTAL

TNX-1300

Intervention Type: DRUG

TNX 1300 200 mg Intravenous injection

Usual Care

Usual Care per the Emergency Department protocol for treating Cocaine Intoxication

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual Care per the Emergency Department protocol for Cocaine Intoxication

Interventions

TNX-1300

TNX 1300 200 mg Intravenous injection

Intervention Type: DRUG

Usual Care

Usual Care per the Emergency Department protocol for Cocaine Intoxication

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Sullivan, MD

Role: STUDY_DIRECTOR

Medical Monitor

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

TNX-CE-CI201

Identifier Type: -

Identifier Source: org_study_id