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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 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.

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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
~24 spots leftby Dec 2024
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