Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)
Public ClinicalTrials.gov record NCT06224127. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT06224127
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 36 participants
Conditions and interventions
Interventions
- active heat Device
- Active c tactile fiber stimulation Drug
- sham heat Device
- Sham c tactile fiber stimulation Device
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 14, 2024
- Primary completion
- Dec 29, 2024
- Completion
- Mar 29, 2025
- Last update posted
- Jan 24, 2024
2024 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Soovu Labs Inbc. | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06224127, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 24, 2024 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06224127 live on ClinicalTrials.gov.