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

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Soovu Labs

Status and phase

Begins enrollment this month
Phase 1

Conditions

Anxiety Disorders
Stress, Psychological
Alcohol Use Disorder

Treatments

Device: Sham c tactile fiber stimulation
Device: active heat
Device: sham heat
Drug: Active c tactile fiber stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT06224127
Soovu01-2024

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A history of AUD within the past six months

Exclusion criteria

Unstable medical or psychological status

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Triple Blind

36 participants in 3 patient groups

Active heat and placebo c tactile stimulation
Active Comparator group
Description:
Subjects will receive an active heating device and a sham c tactile stimulation device.
Treatment:
Device: active heat
Device: Sham c tactile fiber stimulation
Placebo heat and active c tactile stimulation
Active Comparator group
Description:
Subjects will receive an active c tactile stimulation device and a sham heating device.
Treatment:
Drug: Active c tactile fiber stimulation
Device: sham heat
Active heat and active c tactile stimulation
Active Comparator group
Description:
Subjects will receive an active c tactile stimulation device and an active heating device.
Treatment:
Drug: Active c tactile fiber stimulation
Device: active heat

Trial contacts and locations

1

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Central trial contact

charles chabal, MD; Peter Dunbar, MD

Data sourced from clinicaltrials.gov

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