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

Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD) Using a Combination of TRPV-1 Channel and C-tactile Fiber Activation With Measurement of Oxytocin and Cortisol Levels

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorders; Stress, Psychological; Alcohol Use Disorder
• Intervention / Treatment: Device: active heat; Device: Sham c tactile fiber stimulation; Drug: Active c tactile fiber stimulation; Device: sham heat

Detailed Description

36 subjects with a history of AUD within the past six months will be recruited for this study. 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. All subjects will have baseline labs drawn, then undergo 10 minutes of experimental stimulation according to group number 1,2 or 3,After 10 minutes, subjects will be given a validated experimental stressor that takes approximately 15 minutes. During this time, subjects will also receive the experimental stimulation per their experimental group After the experimental stress is concluded, stimulation will continue for an additional 5 minutes. Oxytocin and cortisol via salivary samples will be collected throughout and at the conclusion of the trial. Subjects will be followed for one hour post trial. Both laboratory testing and assessment measures will be repeated at 30 and 60 minutes post experimental treatment. Assessment measures include the VAS-A, the PROMIS anxiety short form, and the desires for alcohol questionnaire. The active placebo is thermal stimulation at 37°C over the trapezius using the same number of heating pods. Placebo CT stimulation will occur by placing the von Frey filaments, which provide two standard deviations less than the optimal pressure. Subjects will not be informed about which group they were randomized into.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: charles chabal, MD; Phone Number: 12065794910; Email: Chuck@Soovu.com
• Study Contact Backup: Name: Peter Dunbar, MD; Email: Peter@soovu.com

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Soovu Labs Inbc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A history of AUD within the past six months

Exclusion Criteria:

Unstable medical or psychological status

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active heat and placebo c tactile stimulation; Subjects will receive an active heating device and a sham c tactile stimulation device.	Device: active heat; Users receive an active Soovu heating pod(s).; Device: Sham c tactile fiber stimulation; Hair brushes that do not activate c tactile fibers
Active Comparator: Placebo heat and active c tactile stimulation; Subjects will receive an active c tactile stimulation device and a sham heating device.	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
Active Comparator: Active heat and active c tactile stimulation; Subjects will receive an active c tactile stimulation device and an active heating device.	Device: active heat; Users receive an active Soovu heating pod(s).; Drug: Active c tactile fiber stimulation; Hair brushes that activate c tactile fibers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxytocin	oxytocin levels	Baseline and every 15 minutes during the study and for 90 minutes post study
cortisol levels	salivary cortisol	Baseline and every 15 minutes during the study and for 90 minutes post study

Collaborators and Investigators

• Sponsor: Soovu Labs Inc.
• Investigators: Principal Investigator: charles chabal, MD, soovu labs

Publications and helpful links

Helpful Links

• description of heating device

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Estimated): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; stress; Alcohol Use Disorder; heat; c-tactile fiber
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism; Anxiety Disorders; Stress, Psychological
• Other Study ID Numbers: Soovu01-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified data records will be available upon request.
• IPD Sharing Time Frame: At study conclusion and for 5 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes