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Cocaine UsePhase 2CATALYSTNCT06045793

Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

A Phase 2 study testing TNX-1300 (Injection) in people with Cocaine Use and Cocaine Intoxication, run by Tonix Pharmaceuticals, Inc. at 6 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
TNX-1300 (Injection)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3 participants
Where
6 sitesUnited States
Study dates
16 Aug 2024to 21 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subject is male or female and is 18-64 years of age.
  • Subject has the capacity to provide voluntary written informed consent. In cases in which the investigator is unclear if the subject has the capacity to consent, a determination regarding capacity must be made by a psychiatrist trained in assessment of capacity to consent to research in order for the subject to be eligible.
  • At Screening, subject presents with cardiac symptoms while intoxicated with cocaine, inclusive of elevated systolic or diastolic BP, as defined below, with or without behavioral symptoms:
  • Systolic BP >140 mmHg, or
  • Diastolic BP >90 mmHg Note: subjects with a QT interval corrected for heart rate (QTc) >500 msec may be eligible for study participation, based on investigator judgment.
  • At Screening and Baseline assessments, subject must have a SIS total score of ≥4
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  • At Baseline, subject has a CGI-S score ≥3.
  • Subject has a positive urine drug screen test at Pre-screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids and/or opioids and remain eligible; subject may test positive for alcohol by breathalyzer and remain eligible).
  • Subject must be willing to practice the following:
  • If female, practice one of the following methods of birth control throughout the study and for 28 days after study drug administration:
  • Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient's usual menstrual cycle period) before study drug administration;
  • Intrauterine device;
  • Bilateral tubal ligation
  • Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jelly or cream);
  • If male, practice double-barrier method throughout the study and for 28 days after study drug administration, if female partner is not following birth control methods a-c mentioned above
  • Subject is a suitable candidate for investigational treatment based on the opinion of the investigator.

Who cannot join

  • Subject who has been admitted to the ED involuntarily.
  • Subject who participated in this clinical study previously.
  • Subject has a score of 3 on the systolic and/or diastolic BP SIS components, a "mental state" or "orientation" SIS component score of ≥2, or an "orientation" SIS component score of ≥1 and the subject is not oriented to either person or place (i.e., only disorientation to time is allowed).
  • Subject who, at Screening, expresses C-SSRS suicidal ideation of Type 4 or 5 in the prior week or any C-SSRS suicidal behavior in the prior week.
  • Subject tests positive for stimulant drugs of abuse other than cocaine, including methylphenidate, 3,4-methylenedioxymethamphetamine, methamphetamine, or other amphetamines at Screening.
  • Subject has a clinically significant untreated cardiac condition, such as prior myocardial infarction, current ischemia assessed by ECG-based criteria, aortic dissection, ventricular fibrillation, Torsade de pointes, ventricular tachycardia, cardiomyopathy, pulmonary edema, cardiac arrest, significant conduction disturbance (e.g., greater than first degree heart block), QRS interval >120 msec, or severe or life-threatening hypertension. Untreated hypertension may be allowed if not considered severe or life-threatening. Note: hypertension will be considered severe or life-threatening if systolic BP is >200 mmHg and/or diastolic BP is >130 mmHg.
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  • 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. Such changes may include new, transient, or dynamic ST-segment elevation, ST-depression, or significant Q waves. Based on investigator judgement, T-wave inversion and T-wave flattening may also be considered in the risk assessment for acute coronary syndrome.
  • Subject has a heart rate ≥180 bpm, atrial fibrillation, greater than first degree heart block, or chest pain with ECG-based evidence of ischemia.
  • Subject has a clinically significant or unstable medical illness, condition, or disorder that can compromise subject safety or adversely affect the evaluation of clinical outcome parameters.
  • Subject has a clinical history of anaphylaxis, severe asthma, hypersensitivity, or angioedema.
  • Subject requires physical restraints due to physiological and/or behavioral symptoms.
  • Subject receives anti-hypertensive medication(s) in the ED prior to study enrollment.
  • Subject is pregnant or breastfeeding.
  • Participation in another investigational drug study (current or within 30 days of Screening) or previous participation in a study of TNX-1300.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University Of Maryland Medical Center

    Baltimore, Maryland, 37601

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Wayne State University

    Detroit, Michigan, 48235

  • Baylor College of Medicine, Ben Taub Hospital

    Houston, Texas, 77030

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Single-Blind, Randomized Study Comparing The Efficacy And Safety Of A Single Dose Of TNX-1300 To Placebo With Usual Care For The Treatment Of Signs And Symptoms Of Acute Cocaine Intoxication In Emergency Department Subjects (CATALYST Study)

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.

Being tested
TNX-1300 (Injection), Placebo (Injection)
Keywords
Emergency Department, Cocaine, Cocaine Intoxication, Cocaine Esterase
Medical subject headings
Cocaine-Related Disorders, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TNX-1300 (Injection)Drug

    Also called Cocaine esterase

    Patients will receive a single IV injection of TNX-1300.

  • Placebo (Injection)Drug

    Patients will receive a single IV injection of placebo with usual care (UC).

Study groups in NCT06045793
Study groupRoleWhat they receive
TNX-1300ExperimentalA single IV 200 mg injection of TNX-1300
Receives: Drug: TNX-1300 (Injection)
PlaceboPlacebo comparatorA single IV injection of placebo with UC
Receives: Drug: Placebo (Injection)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

    Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing.

    Measured: 60 minutes after IV administration

Secondary outcomes (3)

  1. Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC

    Patients will undergo a 12-lead ECG at Baseline and at 15 minutes after dosing.

    Measured: 15 minutes after IV administration

  2. Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

    Patients will undergo a Diastolic BP assessment at Baseline and at 60 minutes after dosing

    Measured: 60 minutes after IV administration

  3. Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

    Patients will be assessed with the SIS for characterizing severity of cocaine intoxication at Baseline and at 60 minutes after dosing. The SIS has 6 items, each of which is scored on a range of 0-3 (4 items) or 0-4 (2 items). The SIS has a total score range of 0 to 20, with 0 being the lowest severity and 20 being the highest severity.

    Measured: 60 minutes after IV administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start16 Aug 2024
  3. Primary completion21 Apr 2025
  4. Study completion21 Apr 2025

Why it stopped: Tonix has discontinued enrollment and terminated the Phase 2 CATALYST study (TNX-CE-CI202) because enrollment in this emergency department-based study was slower than projected. The study was not discontinued for safety or efficacy reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06045793
Sponsor's protocol ID
TNX-CE-CI202
Other IDs
5U01DA056245
Acronym
CATALYST
Status last verified
Jun 2025
First submitted
13 Sep 2023
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TNX-1300 (Injection) in people with Cocaine Use and Cocaine Intoxication, run by Tonix Pharmaceuticals, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Tonix has discontinued enrollment and terminated the Phase 2 CATALYST study (TNX-CE-CI202) because enrollment in this emergency department-based study was slower than projected. The study was not discontinued for safety or efficacy reasons.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC (time frame: 60 minutes after IV administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06045793.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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