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A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances

NCT06685965 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-16

No results posted yet for this study

Summary

Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.

Conditions

  • Posttraumatic Stress Disorder (PTSD)
  • Sleep Disturbances and Insomnia

Interventions

DRUG

RE03

Buccal Dexmedetomidine

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Reconnect Labs

    lead INDUSTRY

Principal Investigators

  • Andres Ort, MD · University of Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-08-01
Completion
2026-08-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT06685965 on ClinicalTrials.gov