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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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06224127
Enrollment
36
Registered
2024-01-25
Start date
2024-07-15
Completion date
2025-03-30
Last updated
2024-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders, Alcohol Use Disorder, Stress, Psychological

Keywords

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

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.

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.

Interventions

DEVICEactive heat

Users receive an active Soovu heating pod(s).

DRUGActive c tactile fiber stimulation

Hair brushes that activate c tactile fibers

DEVICEsham heat

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

DEVICESham c tactile fiber stimulation

Hair brushes that do not activate c tactile fibers

Sponsors

Soovu Labs Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Subjects, assessors and investigators will not know the randomization group assignment.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* A history of AUD within the past six months

Exclusion criteria

Unstable medical or psychological status \-

Design outcomes

Primary

MeasureTime frameDescription
Anxiety ratingat baseline and every 15 minutes during the study and for 90 minutes post studyPatient-Reported Outcomes Measurement Information System anxiety short form, 0-10 with 10 meaning more anxiety and 0 no anxiety
anxiety levelat baseline and every 15 minutes during the study and for 90 minutes post studyVisual analogue scale for anxiety. 0-10 with 10 meaning more anxiety and 0 no anxiety
desires for alcohol questionnaireat baseline and every 30 minutes during the study and for 90 minutes post studydesires for alcohol questionnaire

Secondary

MeasureTime frameDescription
OxytocinBaseline and every 15 minutes during the study and for 90 minutes post studyoxytocin levels
cortisol levelsBaseline and every 15 minutes during the study and for 90 minutes post studysalivary cortisol

Countries

United States

Contacts

Primary Contactcharles chabal, MD
Chuck@Soovu.com12065794910
Backup ContactPeter Dunbar, MD
Peter@soovu.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026