comparing efficacy & safety of tnx-1300 to placebo with uc for treatment of acute cocaine intoxication in ed subjects (catalyst)

Conditions: Cocaine Use; Cocaine Intoxication; Cocaine Toxicity; Cocaine Abuse; Cocaine Adverse Reaction

Summary: this is a phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of tnx-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department setting.


Eligibility criteria:
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 minimum of one full cycle (based on the patient's usual menstrual cycle period) before study drug administration; * intrauterine device; * bilateral tubal ligation * double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jelly or cream); * if male, practice double-barrier method throughout the study and for 28 days after study drug administration, if female partner is not following birth control methods a-c mentioned above * 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 has a score of 3 on the systolic and/or diastolic bp sis components, a "mental state" or "orientation" sis component score of ≥2, or an "orientation" sis component score of ≥1 and the subject is not oriented to either person or place (i.e., only disorientation to time is allowed). * subject who, at screening, expresses c-ssrs suicidal ideation of type 4 or 5 in the prior week or any c-ssrs suicidal behavior in the prior week. * subject tests positive for stimulant drugs of abuse other than cocaine, including methylphenidate, 3,4-methylenedioxymethamphetamine, methamphetamine, or other amphetamines at screening. * subject has a clinically significant untreated cardiac condition, such as prior myocardial infarction, current ischemia assessed by ecg-based criteria, aortic dissection, ventricular fibrillation, torsade de pointes, ventricular tachycardia, cardiomyopathy, pulmonary edema, cardiac arrest, significant conduction disturbance (e.g., greater than first degree heart block), qrs interval \>120 msec, or severe or life-threatening hypertension. untreated hypertension may be allowed if not considered severe or life-threatening. note: hypertension will be considered severe or life-threatening if systolic bp is \>200 mmhg and/or diastolic bp is \>130 mmhg. * 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. such changes may include new, transient, or dynamic st-segment elevation, st-depression, or significant q waves. based on investigator judgement, t-wave inversion and t-wave flattening may also be considered in the risk assessment for acute coronary syndrome. * subject has a heart rate ≥180 bpm, atrial fibrillation, greater than first degree heart block, or chest pain with ecg-based evidence of ischemia. * subject has a clinically significant or unstable medical illness, condition, or disorder that can compromise subject safety or adversely affect the evaluation of clinical outcome parameters. * subject has a clinical history of anaphylaxis, severe asthma, hypersensitivity, or angioedema. * subject requires physical restraints due to physiological and/or behavioral symptoms. * subject receives anti-hypertensive medication(s) in the ed prior to study enrollment. * subject is pregnant or breastfeeding. * participation in another investigational drug study (current or within 30 days of screening) or previous participation in a study of tnx-1300.

Keywords: emergency department cocaine cocaine intoxication cocaine esterase