RecruitingPhase 2NCT06685965

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

A Phase-2, Double-Blind, Randomized, Placebo-controlled, Crossover Dose-Finding, Laboratory-based Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances


Sponsor

Reconnect Labs

Enrollment

24 participants

Start Date

Sep 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental drug called RE03 to see if it helps improve sleep problems in people who have PTSD (post-traumatic stress disorder). **You may be eligible if...** - You are 18–64 years old - You have been diagnosed with PTSD for more than 6 months - You have significant sleep disturbances (difficulty falling or staying asleep, or restless sleep) that have lasted at least a month - You are able to communicate and follow instructions in German **You may NOT be eligible if...** - You work irregular shifts or plan to travel across 2 or more time zones during the study - You have another sleep disorder such as sleep apnea, restless leg syndrome, or narcolepsy - You have bipolar disorder, schizophrenia, obsessive-compulsive disorder, or anorexia - You have a serious heart condition or history of seizures - You are pregnant or breastfeeding - You are currently taking sleep medications, sedatives, or beta-blockers that you cannot stop - You have a recent history of suicidal intent or a suicide attempt in the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRE03

Buccal Dexmedetomidine

DRUGPlacebo

Matching Placebo


Locations(1)

Human Sleep Pharmacology, University of Zurich

Zurich, Canton of Zurich, Switzerland

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NCT06685965


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