NCT06685965

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Reconnect Labs · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants spend one screening night followed by three treatment nights in the sleep lab, where they receive either a low dose, a high dose of dexmedetomidine, or a placebo. All participants receive all three options, with only the sequence differing. Participants and the study team are blinded and thus do not know which dose (or placebo) has been assigned.

Conditions

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

Interventions

Type	Name	Description
DRUG	RE03	Buccal Dexmedetomidine
DRUG	Placebo	Matching Placebo

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-11-13
• Last updated: 2025-09-16

Locations

1 site across 1 country: Switzerland