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

NCT ID: NCT06224127

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-03-30

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.

Conditions

Anxiety Disorders; Alcohol Use Disorder; Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active heat and placebo c tactile stimulation

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

Group Type: ACTIVE_COMPARATOR

active heat

Intervention Type: DEVICE

Users receive an active Soovu heating pod(s).

Sham c tactile fiber stimulation

Intervention Type: DEVICE

Hair brushes that do not activate c tactile fibers

Placebo heat and active c tactile stimulation

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

Group Type: ACTIVE_COMPARATOR

Active c tactile fiber stimulation

Intervention Type: DRUG

Hair brushes that activate c tactile fibers

sham heat

Intervention Type: DEVICE

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

Active heat and active c tactile stimulation

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

Group Type: ACTIVE_COMPARATOR

active heat

Intervention Type: DEVICE

Users receive an active Soovu heating pod(s).

Active c tactile fiber stimulation

Intervention Type: DRUG

Hair brushes that activate c tactile fibers

Interventions

active heat

Users receive an active Soovu heating pod(s).

Intervention Type: DEVICE

Active c tactile fiber stimulation

Hair brushes that activate c tactile fibers

Intervention Type: DRUG

sham heat

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

Intervention Type: DEVICE

Sham c tactile fiber stimulation

Hair brushes that do not activate c tactile fibers

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A history of AUD within the past six months

Exclusion Criteria

Unstable medical or psychological status

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soovu Labs Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

charles chabal, MD

Role: PRINCIPAL_INVESTIGATOR

soovu labs

Locations

Soovu Labs Inbc.

Seattle, Washington, United States

Countries

United States

Central Contacts

charles chabal, MD

Role: CONTACT

Chuck@Soovu.com

12065794910

Peter Dunbar, MD

Role: CONTACT

Peter@soovu.com

Related Links

http://soovu.com

description of heating device

Other Identifiers

Soovu01-2024

Identifier Type: -

Identifier Source: org_study_id