Cocaine Use, Cocaine Intoxication, Cocaine Toxicity, Cocaine Abuse, Cocaine Adverse Reaction
Conditions
Keywords
Emergency Department, Cocaine, Cocaine Intoxication, Cocaine Esterase
Brief 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.
Interventions
DRUGTNX-1300 (Injection)
Patients will receive a single IV injection of TNX-1300.
Patients will receive a single IV injection of placebo with usual care (UC).
Sponsors
National Institute on Drug Abuse (NIDA)
Premier
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to which treatment arm they are assigned to.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC | 60 minutes after IV administration | Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC | 15 minutes after IV administration | Patients will undergo a 12-lead ECG at Baseline and at 15 minutes after dosing. |
| Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC | 60 minutes after IV administration | Patients will undergo a Diastolic BP assessment at Baseline and at 60 minutes after dosing |
| Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC | 60 minutes after IV administration | Patients will be assessed with the SIS for characterizing severity of cocaine intoxication at Baseline and at 60 minutes after dosing. The SIS has 6 items, each of which is scored on a range of 0-3 (4 items) or 0-4 (2 items). The SIS has a total score range of 0 to 20, with 0 being the lowest severity and 20 being the highest severity. |
Countries
United States
Outcome results
None listed