Clinical trial NCT04996056: 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: 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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cocaine Intoxication
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-09
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
timeFrame: Baseline to 12 Hours
Secondary outcomes:
measure: Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)
timeFrame: Baseline to 6 Hours
measure: Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline
timeFrame: Baseline to 6 Hours
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Medical Monitor
name: Gregory Sullivan, MD
role: STUDY_DIRECTOR
References: