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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06224127
• Other study ID #: Soovu01-2024
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 15, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: January 2024
• Source: Soovu Labs Inc.
• Contact: charles chabal, MD
• Phone: 12065794910
• Email: Chuck[@]Soovu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• A history of AUD within the past six months

Exclusion Criteria:

Unstable medical or psychological status

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Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Anxiety Disorders
• Stress, Psychological

Intervention

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
• Sham c tactile fiber stimulation
Hair brushes that do not activate c tactile fibers

Locations

Country	Name	City	State
United States	Soovu Labs Inbc.	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Soovu Labs Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	desires for alcohol questionnaire	desires for alcohol questionnaire	at baseline and every 30 minutes during the study and for 90 minutes post study
Secondary	Oxytocin	oxytocin levels	Baseline and every 15 minutes during the study and for 90 minutes post study
Secondary	cortisol levels	salivary cortisol	Baseline and every 15 minutes during the study and for 90 minutes post study

External Links

•   description of heating device