Clinical trial NCT06224127: Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Anxiety Disorders
Alcohol Use Disorder
Stress, Psychological
Keywords: anxiety
Alcohol Use Disorder
stress
c-tactile fiber
heat
Lead sponsor: Soovu Labs Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* A history of AUD within the past six months

Exclusion Criteria:

Unstable medical or psychological status

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Primary outcomes:
measure: Anxiety rating
timeFrame: at baseline and every 15 minutes during the study and for 90 minutes post study
measure: anxiety level
timeFrame: at baseline and every 15 minutes during the study and for 90 minutes post study
measure: desires for alcohol questionnaire
timeFrame: at baseline and every 30 minutes during the study and for 90 minutes post study
Secondary outcomes:
measure: Oxytocin
timeFrame: Baseline and every 15 minutes during the study and for 90 minutes post study
measure: cortisol levels
timeFrame: Baseline and every 15 minutes during the study and for 90 minutes post study
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Soovu Labs Inbc.
state: Washington
Study officials:
affiliation: soovu labs
name: charles chabal, MD
role: PRINCIPAL_INVESTIGATOR
References: