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

NCT06045793 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-06-24

No results posted yet for this study

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.

Conditions

  • Cocaine Use
  • Cocaine Intoxication
  • Cocaine Toxicity
  • Cocaine Abuse
  • Cocaine Adverse Reaction

Interventions

DRUG

TNX-1300 (Injection)

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

DRUG

Placebo (Injection)

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

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Premier

    collaborator UNKNOWN

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory Sullivan, MD · Tonix Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-16
Primary Completion
2025-04-21
Completion
2025-04-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06045793 on ClinicalTrials.gov