Trial Summary
What is the purpose of this trial?CT fibers are found in the skin of most mammals and project to the insular cortex. Stimulation of CT fibers by light touch causes a release of oxytocin and is associated with feelings of comfort and wellbeing. Peripheral TRPV-1 channels are important in pain transmission and modulation of the stress response likely through the central release of oxytocin and are stimulated by heat. In Phase 1 investigators will test stimulation of TRPV1 channels and CT fibers in human subjects to correlate the lab findings with subjective human responses and test whether stimulation of CT fibers and TRPV-1 channels reduce anxiety and stress in subjects who suffer from AUD. Aim 1 and 2. We will define the optimal parameters for CT fiber stimulation for force, temperature, and body location. We will perform similar testing for peripheral thermal stimulation (TRPV-1) using our commercially available heating pods. Parameters tested will include the optimal body location, number of heating pods (2-4) and temperature of pods. In Aim 3 investigators will simultaneously apply both CT fiber and thermal stimulation in a proof of concept study. The experimental group will receive active CT fiber and thermal stimulation and the control group non-physiologic placebo stimulation. Subjects with a history of AUD will be randomized into control versus experimental groups and undergo stress using a validated mental calculation stressors. Stress, cravings, and anxiety will be measured using standardized assessments, and investigators will measure salivary oxytocin and cortisol levels, potentially biomarkers.
Eligibility Criteria
This trial is for individuals who have had Alcohol Use Disorder (AUD) within the last six months. It's not suitable for those with unstable medical or psychological conditions.Treatment Details
The study tests if stimulating skin fibers and heat channels can reduce stress and anxiety in AUD sufferers. Participants will be split into groups, some getting real stimulation and others placebo, to see which works better.
3Treatment groups
Active Control
Group I: Placebo heat and active c tactile stimulationActive Control2 Interventions
Subjects will receive an active c tactile stimulation device and a sham heating device.
Group II: Active heat and placebo c tactile stimulationActive Control2 Interventions
Subjects will receive an active heating device and a sham c tactile stimulation device.
Group III: Active heat and active c tactile stimulationActive Control2 Interventions
Subjects will receive an active c tactile stimulation device and an active heating device.
Find a clinic near you
Research locations nearbySelect from list below to view details:
Soovu Labs Inbc.Seattle, WA
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Who is running the clinical trial?
Soovu Labs Inc.Lead Sponsor