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NCT06051721RECRUITINGIRB Ready

A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants with Generalized Anxiety Disorder (GAD)

Sponsored by Cybin IRL Limited

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 36 participants interested
3% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this proof-of-concept trial is to examine the safety, tolerability, and pharmacokinetics (PK), and preliminary clinical efficacy of CYB004 participants with GAD.

Who Can Participate

Inclusion Criteria

Aged between 18 to 65 years, inclusive, at Screening.
Has a diagnosis of GAD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-V\] of moderate to severe degree), established through a full psychiatric work up.
Has a BMI of 18 to 40.0 kg/m2, inclusive at Screening.
Has been on a stable dose of antidepressant/anxiolytic medication (no more than 50% change) in the last month prior to Screening and has had an inadequate response, as judged by the Investigator.
Is willing to refrain from taking any benzodiazepines for 5 days or buspirone (or other 5- HT1A agonist) during the 24 hours preceding each dosing visit.
Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria

Has a primary DSM-5 psychiatric diagnosis other than GAD within the past 6 months established through a full psychiatric work-up. A secondary diagn

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

36 participants

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Age Range

18 Years - 65 Years

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Gender

ALL

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Sponsor

Cybin IRL Limited

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Hollywood

Florida

Location available
View Hollywood location page
Unknown

Miami Lakes

Florida

Location available
View Miami Lakes location page
Unknown

Atlanta

Georgia

Location available
View Atlanta location page
Unknown

Decatur

Georgia

Location available
View Decatur location page
Unknown

Chicago

Illinois

Location available
View Chicago location page
Unknown

Murray

Utah

Location available
View Murray location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Generalized Anxiety Disorder Treatment in Miami Lakes?

Join others in Florida exploring innovative treatment options through clinical research

Generalized Anxiety Disorder Treatment Options in Miami Lakes, Florida

If you're searching for Generalized Anxiety Disorder treatment in Miami Lakes, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Miami Lakes, Atlanta, Decatur and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Generalized Anxiety Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 36 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Generalized Anxiety Disorder?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Generalized Anxiety Disorder

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Generalized Anxiety Disorder Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06051721. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.