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

NCT06224127 | Unknown Phase 1 DMC FDA Device

• 1 other identifier: Soovu01-2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anxiety; Alcohol Use Disorder; stress; c-tactile fiber; heat

Outcome Measures

Primary Outcomes (3)

• Anxiety rating

  Patient-Reported Outcomes Measurement Information System anxiety short form, 0-10 with 10 meaning more anxiety and 0 no anxiety

  at baseline and every 15 minutes during the study and for 90 minutes post study

• anxiety level

  Visual analogue scale for anxiety. 0-10 with 10 meaning more anxiety and 0 no anxiety

  at baseline and every 15 minutes during the study and for 90 minutes post study

• desires for alcohol questionnaire

  desires for alcohol questionnaire

  at baseline and every 30 minutes during the study and for 90 minutes post study

Secondary Outcomes (2)

• Oxytocin

  Baseline and every 15 minutes during the study and for 90 minutes post study

• cortisol levels

  Baseline and every 15 minutes during the study and for 90 minutes post study

Study Arms (3)

Active heat and placebo c tactile stimulation

ACTIVE COMPARATOR

Subjects will receive an active heating device and a sham c tactile stimulation device.

Device: active heat; Device: Sham c tactile fiber stimulation

Placebo heat and active c tactile stimulation

ACTIVE COMPARATOR

Subjects will receive an active c tactile stimulation device and a sham heating device.

Drug: Active c tactile fiber stimulation; Device: sham heat

Active heat and active c tactile stimulation

ACTIVE COMPARATOR

Subjects will receive an active c tactile stimulation device and an active heating device.

Device: active heat; Drug: Active c tactile fiber stimulation

Interventions

active heat DEVICE

Users receive an active Soovu heating pod(s).

Active heat and active c tactile stimulation; Active heat and placebo c tactile stimulation

Active c tactile fiber stimulation DRUG

Hair brushes that activate c tactile fibers

Active heat and active c tactile stimulation; Placebo heat and active c tactile stimulation

sham heat DEVICE

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

Placebo heat and active c tactile stimulation

Sham c tactile fiber stimulation DEVICE

Hair brushes that do not activate c tactile fibers

Active heat and placebo c tactile stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of AUD within the past six months

You may not qualify if:

• Unstable medical or psychological status

Sponsors & Collaborators

• Soovu Labs Inc.: lead

Study Sites (1)

Soovu Labs Inbc.

Seattle, Washington, 98109, United States

Location

Related Links

• description of heating device

MeSH Terms

Conditions

Anxiety Disorders; Alcoholism; Stress, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Behavioral Symptoms; Behavior

Study Officials

• charles chabal, MD

  soovu labs

  PRINCIPAL INVESTIGATOR

Central Study Contacts

charles chabal, MD

CONTACT

12065794910; Chuck@Soovu.com

Peter Dunbar, MD

CONTACT

Peter@soovu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, assessors and investigators will not know the randomization group assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized into three groups. Group 1 receives an active heating device and placebo c-tactile fiber stimulation. Group 2 active c tactile fiber stimulation and placebo heating device. Group 3 receives active c tactile fiber stimulation and an active heating device.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 25, 2024
• Study Start: July 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At study conclusion and for 5 years

Locations

US (1)