Trials / Active Not Recruiting
Active Not RecruitingNCT06051721
A Study of a N, N-dimethyltryptamine (DMT) Analog (CYB004) in Participants With Generalized Anxiety Disorder (GAD)
A Phase 2a, Randomized, Double-Blind, Active-Controlled Study to Assess the Preliminary Clinical Efficacy, Safety, Tolerability, and Pharmacokinetics, of CYB004 in Participants With Generalized Anxiety Disorder (GAD)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Cybin IRL Limited · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CYB004 | CYB004 is a synthetic deuterated N, N-Dimethyltryptamine (DMT) analog. |
| BEHAVIORAL | Psychotherapy | Manualized psychotherapy (called EMBARK) performed by facilitators |
Timeline
- Start date
- 2024-05-10
- Primary completion
- 2025-10-14
- Completion
- 2026-09-01
- First posted
- 2023-09-25
- Last updated
- 2025-10-27
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06051721. Inclusion in this directory is not an endorsement.