NCT06224127

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

Status unknown Phase 1 Last updated 25 January 2024

What this trial tests

Phase 1 trial testing active heat in Anxiety Disorders in 36 participants. Status unknown.

Timeline

15 July 2024

Primary endpoint
30 December 2024

30 March 2025

Quick facts

Lead sponsor	Soovu Labs Inc.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	36
Start date	15 July 2024
Primary completion	30 December 2024
Estimated completion	30 March 2025
Sites	1 location across United States

Drugs / interventions tested

• active heat
• Active c tactile fiber stimulation — full drug profile →
• sham heat
• Sham c tactile fiber stimulation

Conditions studied

• Anxiety Disorders — all drugs for Anxiety Disorders →
• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →
• Stress, Psychological — all drugs for Stress, Psychological →

Sponsor

Soovu Labs Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Anxiety Disorders or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging medications and pharmacological treatment approaches for substance use disorders.
   Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, et al · · 2025 · cited 2× · PMID 39719161 · DOI 10.1016/j.pbb.2024.173952