TNX-1300 for Cocaine Intoxication

(CATALYST Trial)

No longer recruiting at 7 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TNX-1300 for individuals arriving at the emergency room due to cocaine overdose. The goal is to compare the effectiveness of TNX-1300 to a placebo, a harmless substance used to evaluate the real treatment's effectiveness. The trial seeks participants who have used cocaine and are experiencing heart-related symptoms, such as high blood pressure, while intoxicated. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that TNX-1300 is likely to be safe for humans?

Research is examining the safety of TNX-1300 for treating sudden cocaine overdose. Earlier studies have assessed whether TNX-1300 can safely reduce high blood pressure caused by cocaine, a serious issue during an overdose.

Specific details about side effects in people are not yet available, but TNX-1300's progression to Phase 2 trials indicates earlier tests found it to be fairly safe. Treatments reaching this stage have generally demonstrated some safety in humans in previous trials.

Researchers are testing TNX-1300 as a single 200 mg injection into a vein, focusing on its safety and effectiveness against cocaine overdose symptoms. Ongoing research will provide more detailed information on how well patients tolerate the treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for cocaine intoxication, which typically involves supportive care and medications to manage symptoms, TNX-1300 works by breaking down cocaine directly in the bloodstream. This treatment uses a unique enzyme called cocaine esterase, which rapidly degrades cocaine, potentially providing a faster and more targeted response than current methods. Researchers are excited because TNX-1300 could reduce the effects of cocaine intoxication much more quickly and specifically than existing treatments, offering a significant breakthrough in managing this condition.

What evidence suggests that TNX-1300 might be an effective treatment for cocaine intoxication?

Research shows that TNX-1300, which participants in this trial may receive, could be a helpful treatment for cocaine overdose. Earlier studies showed promise in reducing the dangerous, life-threatening symptoms of a cocaine overdose. TNX-1300 breaks down cocaine in the blood, helping to lower harmful effects like high blood pressure. Although specific trial data is not provided here, researchers are actively studying the treatment to ensure its safety and effectiveness. Early results suggest it could be useful in emergency situations to help manage cocaine overdose. ^{1 2 4 6 7}

Who Is on the Research Team?

Gregory Sullivan, MD

Principal Investigator

Tonix Pharmaceuticals

Are You a Good Fit for This Trial?

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

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.

At the initial and follow-up examinations, participants must have a SIS total score of at least 4 points and a score higher than 1 on either systolic or diastolic blood pressure.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1507/tonix-pharmaceuticals-announces-first-patient-enrolled-in

Tonix Pharmaceuticals Announces First Patient Enrolled in ... The primary endpoint of the study is reduction of systolic blood pressure associated with acute cocaine intoxication identified at study ...

2. reporter.nih.gov reporter.nih.gov/project-details/10479743

TNX-1300 The proposed project involves the development of a promising and novel candidate medication, TNX-1300, for the treatment of acute, life-threatening cocaine ...

3. docs.publicnow.com docs.publicnow.com/E9187B9E4690D2EEC2CE93124F3660B7B627958C

TNX-1300 - Cocaine Intoxication (2021). Results from the 2020 National Survey on. Drug Use and Health: Detailed Tables: Prevalence Estimates, Standard Errors, and Sample Sizes.

4. ctv.veeva.com ctv.veeva.com/study/comparing-efficacy-safety-of-tnx-1300-to-placebo-with-uc-for-treatment-of-acute-cocaine-intoxicati

Comparing Efficacy & Safety Of TNX-1300 To Placebo With ... 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 ...

5. withpower.com withpower.com/trial/phase-2-poisoning-9-2023-0c541

TNX-1300 for Cocaine Intoxication (CATALYST 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 ...

6. docs.publicnow.com docs.publicnow.com/viewDoc.aspx?filename=168141%5CEXT%5C02C5940374F0C04BCC05A8199EF001F9EF94EA14_492673BE85DA4ECCDB6867247835F4C8A50034AC.PDF

TNX-1300 - Cocaine Intoxication (2021). Results from the 2020 National Survey on. Drug Use and Health: Detailed Tables: Prevalence Estimates, Standard Errors, and Sample Sizes.

7. ir.tonixpharma.com ir.tonixpharma.com/news-events/press-releases/detail/1327/tonix-pharmaceuticals-announces-trial-design-of-new-phase-2

Tonix Pharmaceuticals Announces Trial Design of New ... The Phase 2 trial is a single-blind, open-label, placebo-controlled, randomized study comparing the safety of a single 200 mg dose of TNX-1300 ...