TNX-1300 for Cocaine Intoxication

(CATALYST Trial)

Recruiting at 6 trial locations

Overseen By Clinical Trials Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Tonix Pharmaceuticals, Inc.

Must not be taking: Stimulants

Disqualifiers: Severe cardiac conditions, Suicidal ideation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you receive anti-hypertensive medication in the emergency department before joining the study, you cannot participate.

Is TNX-1300 safe for humans?

There is no specific safety data available for TNX-1300 in the provided research articles. ^{1 2 3 4 5}

Research Team

Gregory Sullivan, MD

Principal Investigator

Tonix Pharmaceuticals

Eligibility Criteria

This trial is for males aged 18-64 who've used cocaine and are now in the emergency department with acute intoxication. They must be able to consent, have certain blood pressure levels, and a specific severity of symptoms. Those with mixed drug use may still qualify but it's up to the doctor's judgment.

Inclusion Criteria

You are between 18 and 64 years old.

Subjects must be able to provide voluntary, informed consent and if investigator is unsure of the capacity, a psychiatrist trained in research-related assessments should make the determination for eligibility.

You have a diastolic blood pressure higher than 90 mmHg, and you may be eligible for study participation if your QTc interval is greater than 500 msec at the investigator's discretion.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single IV injection of TNX-1300 or placebo with usual care for acute cocaine intoxication

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of blood pressure and ECG

1 day

1 visit (in-person)

Treatment Details

Interventions

• TNX-1300

Trial Overview The study compares TNX-1300, a potential new treatment for cocaine overdose, against a placebo injection. Participants receive usual care plus one of these injections at random in an emergency department setting to see which is more effective.

Participant Groups

Group I: TNX-1300 Experimental Treatment 1 Intervention

A single IV 200 mg injection of TNX-1300

Group II: Placebo Placebo Group 1 Intervention

A single IV injection of placebo with UC

Who Is Running the Clinical Trial?

Tonix Pharmaceuticals, Inc.

Lead Sponsor

Trials

31

Recruited

4,900+

Premier

Collaborator

Trials

2

Recruited

120+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Out of 68 investigated deaths related to cocaine use, 24 were directly caused by cocaine toxicity, highlighting its dangerous effects, especially with intravenous use leading to rapid respiratory collapse.

The study found that the method of cocaine ingestion affects the timing and severity of symptoms, with oral or nasal use causing a delay before sudden seizures and death, emphasizing that cocaine is not a safe recreational drug.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Death caused by recreational cocaine use. Wetli, CV., Wright, RK.[2022]

Cocaine use leads to severe health issues, including trauma and cardiovascular collapse, requiring emergency departments to be prepared for life-threatening situations.

Effective treatment of cocaine intoxication involves understanding the risks and benefits of various interventions, including pharmacologic and surgical options, to address the complex vascular effects of cocaine toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cardiovascular effects of cocaine. Goldfrank, LR., Hoffman, RS.[2019]

GHB is identified as the most physiologically toxic substance among GHB, ketamine, MDMA, and Rohypnol, while Rohypnol is considered the least toxic based on a safety ratio calculated from lethal and recreational doses.

The combination of psychoactive substances, particularly with alcohol, poses the highest risk for dangerous behaviors among club drug users, leading to potential accidents and aggressive actions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxic effects of club drugs. Gable, RS.[2019]

In a study involving 12 dogs, high doses of cocaine (5.25 mg/kg) led to significant decreases in mean arterial pressure by up to 32%, indicating severe cardiovascular effects, while low doses (3.5 mg/kg) initially increased mean arterial pressure by up to 31%.

Both high and low doses of cocaine caused QRS prolongation on electrocardiograms, with high doses showing a more pronounced and cumulative effect, which raises concerns about potential dysrhythmias and cardiovascular collapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerance develops to the sympathomimetic but not the local anesthetic effects of cocaine. Wilson, LD., Jeromin, G., Shelat, C., et al.[2019]

The study provides a detailed clinical and biological analysis of a fatal cocaine overdose, highlighting the severe physiological effects and complications associated with high doses of cocaine.

Understanding the therapeutic interventions and outcomes in this case can inform medical professionals about the critical management strategies required for cocaine overdose situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A case of fatal cocaine overdose]. Berny, C., Cohen, S., Caselagno, JS., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Death caused by recreational cocaine use. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The cardiovascular effects of cocaine. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Acute toxic effects of club drugs. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Tolerance develops to the sympathomimetic but not the local anesthetic effects of cocaine. [2019]

5. France pubmed.ncbi.nlm.nih.gov

[A case of fatal cocaine overdose]. [2013]