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Behavioural Intervention

Active heat and active c tactile stimulation for Alcoholism

Phase 1

Waitlist Available

Led By charles chabal, MD

Research Sponsored by Soovu Labs Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 15 minutes during the study and for 90 minutes post study

Awards & highlights

Study Summary

This trial aims to study the effects of stimulating certain nerve fibers in the skin on reducing anxiety and stress in people with AUD (alcohol use disorder). These nerve fibers, called CT fibers, are responsible

Who is the study for?

This trial is for individuals who have had Alcohol Use Disorder (AUD) within the last six months. It's not suitable for those with unstable medical or psychological conditions.Check my eligibility

What is being tested?

The study tests if stimulating skin fibers and heat channels can reduce stress and anxiety in AUD sufferers. Participants will be split into groups, some getting real stimulation and others placebo, to see which works better.See study design

What are the potential side effects?

Since this trial involves non-invasive stimulation of skin fibers and heat channels rather than drugs, side effects may include local discomfort at the site of stimulation but are expected to be minimal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and every 15 minutes during the study and for 90 minutes post study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and every 15 minutes during the study and for 90 minutes post study

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and every 15 minutes during the study and for 90 minutes post study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety rating

anxiety level

desires for alcohol questionnaire

Secondary outcome measures

Oxytocin

cortisol levels

Trial Design

3Treatment groups

Active Control

Group I: Placebo heat and active c tactile stimulationActive Control2 Interventions

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

Group II: Active heat and placebo c tactile stimulationActive Control2 Interventions

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

Group III: Active heat and active c tactile stimulationActive Control2 Interventions

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Soovu Labs Inc.Lead Sponsor

4 Previous Clinical Trials

200 Total Patients Enrolled

charles chabal, MDPrincipal Investigatorsoovu labs

2 Previous Clinical Trials

140 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research endeavor?

"In order to be eligible for inclusion in this clinical trial, prospective participants must experience stress and fall between the ages of 18 and 75. The study has capacity for a total of 36 individuals."

Answered by AI

Has the Food and Drug Administration granted approval for active heat therapy and active c tactile stimulation?

"Based on the phase of this trial, which is Phase 1, our team at Power estimates the safety rating for Active heat and active c tactile stimulation to be a 1. This indicates that there is limited data available supporting both safety and efficacy."

Answered by AI

Are there any age restrictions for potential participants in this clinical trial, specifically with regards to individuals over the age of 35?

"To be eligible for participation in this clinical trial, individuals must fall within the age range of 18 to 75 years old. It is worth noting that there are a total of 173 trials available specifically for participants under the age of 18 and an additional 579 trials catering to patients over the age of 65."

Answered by AI

Is this research study currently accepting new participants?

"According to the information available on clinicaltrials.gov, this specific trial is currently not seeking participants. It was initially posted on July 15th, 2024 and last updated on January 24th, 2024. However, it's worth noting that there are presently 875 other ongoing studies actively recruiting individuals for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Treating Stress and Anxiety in Individuals With Alcohol Use Disorder (AUD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06224127.

All > Anxiety Disorder > Anxiety