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

Study Overview
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Brief Summary
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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

Official Title
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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
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Cocaine Intoxication

Intervention / Treatment
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* Drug: TNX-1300
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male (sex assigned at birth). Subject is 18-50 years of age. Subject has the capacity to provide voluntary written informed consent. 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). At Screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms. 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). Subject is a suitable candidate for investigational treatment based on the opinion of the investigator. Exclusion Criteria: Subject who has been admitted to the ED involuntarily. Subject who participated in this clinical study previously. Subject received naloxone (Narcan) within 3 hours prior to informed consent. Subject tests positive for 3,4-Methylenedioxymethamphetamine (MDMA) or amphetamine at Screening. Subject has a prior or current clinically significant untreated cardiac condition. Untreated hypertension may be allowed if not considered severe or life threatening. 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. 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. Subject requires physical restraints due to physiological and/or behavioral symptoms. Participation in another investigational drug study (current or within 30 days of Screening).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNX-1300<br>TNX-1300 Intravenous injection 200 mg once over 2 mins | Drug: TNX-1300<br>* TNX 1300 200 mg Intravenous injection<br>|
| Other: Usual Care<br>Usual Care per the Emergency Department protocol for treating Cocaine Intoxication | Other: Usual Care<br>* Usual Care per the Emergency Department protocol for Cocaine Intoxication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions | Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions | Baseline to 12 Hours | 

Secondary Outcome Measures

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