Anxiety DisordersPhase 1NCT06224127
Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)
A Phase 1 study testing active heat and Active c tactile fiber stimulation in people with Anxiety Disorders and Alcohol Use Disorder, run by Soovu Labs Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anxiety Disorders, Alcohol Use Disorder, Stress, Psychological
- What is being tested?
- active heat and Active c tactile fiber stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2024to 30 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of AUD within the past six months
Who cannot join
- Unstable medical or psychological status
- -
Trial locations and contacts
1 site in 1 country.
Peter Dunbar, MD contact
About this study
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
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.
Read the 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.
- Being tested
- active heat, Active c tactile fiber stimulation, sham heat, Sham c tactile fiber stimulation
- Keywords
- anxiety, Alcohol Use Disorder, stress, c-tactile fiber, heat
- Medical subject headings
- Anxiety Disorders, Alcoholism, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active heatDevice
Users receive an active Soovu heating pod(s).
Active c tactile fiber stimulationDrug
Hair brushes that activate c tactile fibers
sham heatDevice
A Soovu heating pod(s) in the subtherapeutic temperature range
Sham c tactile fiber stimulationDevice
Hair brushes that do not activate c tactile fibers
| Study group | Role | What they receive |
|---|---|---|
| Active heat and placebo c tactile stimulation | Active comparator | Subjects will receive an active heating device and a sham c tactile stimulation device. Receives: Device: active heat; Device: Sham c tactile fiber stimulation |
| Placebo heat and active c tactile stimulation | Active comparator | Subjects will receive an active c tactile stimulation device and a sham heating device. Receives: Drug: Active c tactile fiber stimulation; Device: sham heat |
| Active heat and active c tactile stimulation | Active comparator | Subjects will receive an active c tactile stimulation device and an active heating device. Receives: Device: active heat; Drug: Active c tactile fiber stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety rating
Patient-Reported Outcomes Measurement Information System anxiety short form, 0-10 with 10 meaning more anxiety and 0 no anxiety
Measured: at baseline and every 15 minutes during the study and for 90 minutes post study
anxiety level
Visual analogue scale for anxiety. 0-10 with 10 meaning more anxiety and 0 no anxiety
Measured: at baseline and every 15 minutes during the study and for 90 minutes post study
desires for alcohol questionnaire
desires for alcohol questionnaire
Measured: at baseline and every 30 minutes during the study and for 90 minutes post study
Secondary outcomes (2)
Oxytocin
oxytocin levels
Measured: Baseline and every 15 minutes during the study and for 90 minutes post study
cortisol levels
salivary cortisol
Measured: Baseline and every 15 minutes during the study and for 90 minutes post study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start15 Jul 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soovu Labs Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- charles chabal, MD, Principal investigator, soovu labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224127
- Sponsor's protocol ID
- Soovu01-2024
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All de-identified data records will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06224127
- Acronym / sponsor ID
- Soovu01-2024
- Keywords
- anxiety, Alcohol Use Disorder, stress, c-tactile fiber, heat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Soovu Labs Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active heat and placebo c tactile stimulation | Active comparator | Device: active heat, Device: Sham c tactile fiber stimulationSubjects will receive an active heating device and a sham c tactile stimulation device. |
| Placebo heat and active c tactile stimulation | Active comparator | Drug: Active c tactile fiber stimulation, Device: sham heatSubjects will receive an active c tactile stimulation device and a sham heating device. |
| Active heat and active c tactile stimulation | Active comparator | Device: active heat, Drug: Active c tactile fiber stimulationSubjects will receive an active c tactile stimulation device and an active heating device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A history of AUD within the past six months
Key exclusion criteria (2 listed)
- Unstable medical or psychological status
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active heatUsers receive an active Soovu heating pod(s). | Device | Active heat and active c tactile stimulation, Active heat and placebo c tactile stimulation |
| Active c tactile fiber stimulationHair brushes that activate c tactile fibers | Drug | Active heat and active c tactile stimulation, Placebo heat and active c tactile stimulation |
| sham heatA Soovu heating pod(s) in the subtherapeutic temperature range | Device | Placebo heat and active c tactile stimulation |
| Sham c tactile fiber stimulationHair brushes that do not activate c tactile fibers | Device | Active heat and placebo c tactile stimulation |
Primary outcome
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
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
2 secondary outcomes
Oxytocin
Time frame: Baseline and every 15 minutes during the study and for 90 minutes post study
cortisol levels
Time frame: Baseline and every 15 minutes during the study and for 90 minutes post study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: Yes. All de-identified data records will be available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Dunbar, MD contact
charles chabal, MD principal investigator
soovu labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing active heat and Active c tactile fiber stimulation in people with Anxiety Disorders and Alcohol Use Disorder, run by Soovu Labs Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact charles chabal, MD (12065794910, Chuck@Soovu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety rating (time frame: at baseline and every 15 minutes during the study and for 90 minutes post study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024; AzTrials last refreshed its copy on 8 Nov 2026.