Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

Inclusion Criteria: * Subject is male or female and is 18-64 years of age. * Subject has the capacity to provide voluntary written informed consent. In cases in which the investigator is unclear if the subject has the capacity to consent, a determination regarding capacity must be made by a psychiatrist trained in assessment of capacity to consent to research in order for the subject to be eligible. * At Screening, subject presents with cardiac symptoms while intoxicated with cocaine, inclusive of elevated systolic or diastolic BP, as defined below, with or without behavioral symptoms: * Systolic BP \>140 mmHg, or * Diastolic BP \>90 mmHg Note: subjects with a QT interval corrected for heart rate (QTc) \>500 msec may be eligible for study participation, based on investigator judgment. * At Screening and Baseline assessments, subject must have a SIS total score of ≥4 * At Baseline, subject has a CGI-S score ≥3. * Subject has a positive urine drug screen test at Pre-screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids and/or opioids and remain eligible; subject may test positive for alcohol by breathalyzer and remain eligible). * Subject must be willing to practice the following: * If female, practice one of the following methods of birth control throughout the study and for 28 days after study drug administration: * Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minim…