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Clinical Trials/NCT06224127
NCT06224127Not yet recruitingPhase 1

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

Soovu Labs Inc.1 site in 1 country36 target enrollmentStarted: July 15, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Not yet recruiting
Enrollment
36
Locations
1
Primary Endpoint
desires for alcohol questionnaire

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • A history of AUD within the past six months

Exclusion Criteria

  • Unstable medical or psychological status

Arms & Interventions

Active heat and placebo c tactile stimulation

Active Comparator

Subjects will receive an active heating device and a sham c tactile stimulation device.

Intervention: active heat (Device)

Active heat and placebo c tactile stimulation

Active Comparator

Subjects will receive an active heating device and a sham c tactile stimulation device.

Intervention: Sham c tactile fiber stimulation (Device)

Placebo heat and active c tactile stimulation

Active Comparator

Subjects will receive an active c tactile stimulation device and a sham heating device.

Intervention: Active c tactile fiber stimulation (Drug)

Placebo heat and active c tactile stimulation

Active Comparator

Subjects will receive an active c tactile stimulation device and a sham heating device.

Intervention: sham heat (Device)

Active heat and active c tactile stimulation

Active Comparator

Subjects will receive an active c tactile stimulation device and an active heating device.

Intervention: active heat (Device)

Active heat and active c tactile stimulation

Active Comparator

Subjects will receive an active c tactile stimulation device and an active heating device.

Intervention: Active c tactile fiber stimulation (Drug)

Outcomes

Primary Outcomes

desires for alcohol questionnaire

Time Frame: at baseline and every 30 minutes during the study and for 90 minutes post study

desires for alcohol questionnaire

Anxiety rating

Time Frame: at baseline and every 15 minutes during the study and for 90 minutes post study

Patient-Reported Outcomes Measurement Information System anxiety short form, 0-10 with 10 meaning more anxiety and 0 no anxiety

anxiety level

Time Frame: at baseline and every 15 minutes during the study and for 90 minutes post study

Visual analogue scale for anxiety. 0-10 with 10 meaning more anxiety and 0 no anxiety

Secondary Outcomes

  • Oxytocin(Baseline and every 15 minutes during the study and for 90 minutes post study)
  • cortisol levels(Baseline and every 15 minutes during the study and for 90 minutes post study)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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