Nerve Fiber Stimulation for Alcoholism

PD
cc
Overseen Bycharles chabal, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Soovu Labs Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if certain types of stimulation can reduce stress and anxiety in individuals with Alcohol Use Disorder (AUD). Researchers are testing two methods: C Tactile Fiber Stimulation, which uses gentle touch to release feel-good hormones, and Heat Stimulation, which applies heat to potentially ease stress. Participants will be assigned to different groups to try these methods, and their stress and cravings will be measured. This trial suits those who have experienced AUD in the past six months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nerve fiber stimulation technique is safe for humans?

Research has shown that a gentle touch, known as C Tactile (CT) fiber stimulation, can improve mood. One study found that this type of touch can help people with Alcohol Use Disorder (AUD) feel better and less stressed, suggesting it might be safe and comfortable for use.

In contrast, using heat as a treatment carries some risks. Evidence shows that alcohol can alter how people perceive heat, sometimes increasing sensitivity. However, research also indicates that alcohol can reduce heat pain in controlled settings.

Both treatments are in the early testing stages, with researchers primarily assessing their safety. The current goal is to ensure these methods are safe before evaluating their effectiveness. While the results are promising, further research is needed to fully confirm their safety.12345

Why are researchers excited about this trial's treatments?

Most treatments for alcoholism, like medications and behavioral therapies, aim to reduce cravings or manage withdrawal symptoms. However, this new approach using nerve fiber stimulation is unique because it targets specific nerve fibers in the skin, known as C tactile fibers, which might influence the brain's reward system differently. Researchers are excited because this method could offer a non-invasive alternative with potentially fewer side effects compared to medications. The combination of active C tactile fiber and heat stimulation may also provide a novel way to modulate neural pathways associated with addiction, offering hope for more effective and accessible treatments.

What evidence suggests that this trial's treatments could be effective for alcoholism?

This trial will compare different methods of nerve fiber stimulation for Alcohol Use Disorder (AUD). Research has shown that stimulating certain nerve fibers related to comfort, such as through C Tactile Fiber Stimulation, can help reduce heart rate changes caused by alcohol triggers in people with AUD, potentially having a calming effect during early recovery. Additionally, using heat stimulation to target specific stress-related channels in the body has shown promise in reducing problematic drinking. In one study, participants experienced a 14% decrease in problematic drinking and an 11% reduction in cravings after using heat therapy. Both methods focus on reducing stress and anxiety, which are important in managing AUD. These findings suggest potential benefits for reducing alcohol cravings and stress in people with AUD. Participants in this trial will receive either active or placebo versions of these treatments to evaluate their effectiveness.36789

Who Is on the Research Team?

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charles chabal, MD

Principal Investigator

soovu labs

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

A history of AUD within the past six months

Exclusion Criteria

Unstable medical or psychological status

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive experimental stimulation of TRPV-1 channels and CT fibers, followed by a stressor and further stimulation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 30 and 60 minutes post-treatment

90 minutes

What Are the Treatments Tested in This Trial?

Interventions

  • C Tactile Fiber Stimulation
  • Heat Stimulation
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Active Control
Group I: Placebo heat and active c tactile stimulationActive Control2 Interventions
Group II: Active heat and placebo c tactile stimulationActive Control2 Interventions
Group III: Active heat and active c tactile stimulationActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Soovu Labs Inc.

Lead Sponsor

Trials
5
Recruited
240+

Citations

CT-optimal touch modulates alcohol-cue-elicited heart rate ...CT-optimal touch modulates alcohol-cue-elicited heart rate variability in alcohol use disorder patients during early abstinence: A randomized controlled study.
Mechanically-evoked C-fiber activity in painful alcohol and ...We compared changes in mechanically-evoked C-fiber activity, in models of painful peripheral neuropathy induced by drinking ethanol (alcohol) or administering 2 ...
CT-optimal touch modulates alcohol-cue-elicited heart rate ...CT-optimal touch modulates alcohol-cue-elicited heart rate variability in Alcohol Use Disorder patients during early abstinence: a randomized ...
Somatosensory profiling of patients undergoing alcohol ...An integrated treatment incorporating both pain management and relapse prevention was shown to be effective in a small sample of patients with ...
Alternating bilateral sensory stimulation alleviates alcohol- ...In this study, we find that 4-Hz alternating bilateral sensory stimulation (ABS) effectively reduces ethanol-induced conditioned place ...
Alcohol use and the pain system - PMC - PubMed Central - NIHIndeed, c-FOS activation following acute ethanol administration causes c-FOS activation to decline (desensitize) in the PB and other alcohol ...
C-tactile afferent stimulating touch carries a positive affective ...These results offer the first empirical evidence in humans that tactile stimulation that optimally activates CTs carries a positive affective valence.
Alcoholic neuropathy associated with chronic alcohol intakeOur data showed a peripheral effect of chronic alcohol intake associated with hyperalgesia and a process of demyelination with a strong correlation with alcohol ...
Chronic alcohol-induced brain states limit propagation of ...The impact of chronic alcohol consumption is evident in disruptions within prefrontal circuitries, resulting in cognitive deficits that ...
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