Back to resultsAn 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
Primary Purpose
Cocaine Intoxication
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TNX-1300
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Cocaine Intoxication
Eligibility Criteria
Inclusion Criteria:
- Subject is male (sex assigned at birth).
- Subject is 18-50 years of age.
- Subject has the capacity to provide voluntary written informed consent.
- 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).
- At Screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms.
- 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).
- 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 received naloxone (Narcan) within 3 hours prior to informed consent.
- Subject tests positive for 3,4-Methylenedioxymethamphetamine (MDMA) or amphetamine at Screening.
- Subject has a prior or current clinically significant untreated cardiac condition. Untreated hypertension may be allowed if not considered severe or life threatening.
- 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.
- 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.
- Subject requires physical restraints due to physiological and/or behavioral symptoms.
- Participation in another investigational drug study (current or within 30 days of Screening).
Sites / Locations
- Henry Ford Hospital
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
TNX-1300
Usual Care
Arm Description
TNX-1300 Intravenous injection 200 mg once over 2 mins
Usual Care per the Emergency Department protocol for treating Cocaine Intoxication
Outcomes
Primary Outcome Measures
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
Secondary Outcome Measures
Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)
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
Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline
Full Information
NCT ID
NCT04996056
First Posted
August 3, 2021
Last Updated
June 23, 2022
Sponsor
Tonix Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04996056
Brief 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
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not able to recruit qualified participants
Study Start Date
September 3, 2021 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Intoxication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNX-1300
Arm Type
Experimental
Arm Description
TNX-1300 Intravenous injection 200 mg once over 2 mins
Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual Care per the Emergency Department protocol for treating Cocaine Intoxication
Intervention Type
Drug
Intervention Name(s)
TNX-1300
Intervention Description
TNX 1300 200 mg Intravenous injection
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care per the Emergency Department protocol for Cocaine Intoxication
Primary Outcome Measure Information:
Title
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
Description
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
Time Frame
Baseline to 12 Hours
Secondary Outcome Measure Information:
Title
Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)
Description
Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)
Time Frame
Baseline to 6 Hours
Title
Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline
Description
Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline
Time Frame
Baseline to 6 Hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is male (sex assigned at birth).
Subject is 18-50 years of age.
Subject has the capacity to provide voluntary written informed consent.
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).
At Screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms.
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).
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 received naloxone (Narcan) within 3 hours prior to informed consent.
Subject tests positive for 3,4-Methylenedioxymethamphetamine (MDMA) or amphetamine at Screening.
Subject has a prior or current clinically significant untreated cardiac condition. Untreated hypertension may be allowed if not considered severe or life threatening.
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.
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.
Subject requires physical restraints due to physiological and/or behavioral symptoms.
Participation in another investigational drug study (current or within 30 days of Screening).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Sullivan, MD
Organizational Affiliation
Medical Monitor
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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
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