Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)

Summary

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.

Conditions

• Anxiety Disorders
• Alcohol Use Disorder
• Stress, Psychological

Interventions

DEVICE

active heat

Users receive an active Soovu heating pod(s).

DRUG

Active c tactile fiber stimulation

Hair brushes that activate c tactile fibers

DEVICE

sham heat

A Soovu heating pod(s) in the subtherapeutic temperature range

DEVICE

Sham c tactile fiber stimulation

Hair brushes that do not activate c tactile fibers

Sponsors & Collaborators

• Soovu Labs Inc.

  lead INDUSTRY

Principal Investigators

• charles chabal, MD · soovu labs

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-15

Primary Completion

2024-12-30

Completion

2025-03-30

FDA Device

Yes

Countries

• United States

Study Locations