Cocaine Intoxication
Conditions
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
Interventions
DRUGTNX-1300
TNX 1300 200 mg Intravenous injection
OTHERUsual Care
Usual Care per the Emergency Department protocol for Cocaine Intoxication
Sponsors
Tonix Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions | Baseline to 12 Hours | Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS) |
| 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 | Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline |
Countries
United States
Outcome results
None listed