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Vagus Nerve Stimulation for Alcoholism
Study Summary
This trial is testing whether stimulating the vagus nerve can help people with alcohol use disorder by reducing cravings and improving quality of life. The study will also look at whether this treatment alters brain activity related to perception and awareness of distress and pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't had major surgery or uncontrolled illness in the last month.You can go without drinking alcohol for one day without feeling sick or experiencing hallucinations or tremors.You have a current diagnosis of alcohol use disorder (AUD) with at least one functional disability due to alcohol use, current alcohol craving, and current heavy drinking (>4 drinks on any day or >14 drinks per week).I have a history of heart issues, stroke, seizures, or neck surgery.I am a man aged between 21 and 65.I have a neurological condition that could affect my thinking or memory.You are a former member of the military.I am a man aged between 21 and 65.
- Group 1: Active cervical transcutaneous vagus nerve stimulation
- Group 2: Sham cervical transcutaneous vagus nerve stimulation
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How conducive is Active cervical transcutaneous vagus nerve stimulation to patient well-being?
"With limited evidence for safety and efficacy, Active cervical transcutaneous vagus nerve stimulation received a low score of 1."
Is eligibility open to participate in this experiment?
"This medical experiment is enrolling 16 adults who suffer from alcoholism. These participants must have attained the age of majority, be male, and between 21 to 65 years old. Moreover, they need to meet criteria for a DSM-5 diagnosis of AUD with an associated life impairment due to alcohol consumption; as well as present cravings and regular binging behaviour (>4 units on any day or >14 drinks per week)."
What are the anticipated results of this clinical investigation?
"During this clinical trial, the primary outcome measure to assess efficacy and treatment adherence will be observed over a baseline period extending from week 1 of 2x daily intervention. Secondary evaluation variables include Substance Use Recovery Evaluator (SURE), WHO Quality of Life assessment (WHOQOL-BREF) and PROMIS Pain Interference. These metrics range in scale from 3 point scales up to 5 point scales with score interpretations varying between items."
Are there any openings remaining to participate in this trial?
"Affirmative. Clinicaltrials.gov data indicates that this study, which was initially announced on April 1st 2022, is actively recruiting volunteers. Approximately 16 participants must be sourced from one medical centre for the trial to progress."
Does this research encompass persons of advanced age?
"This clinical trial's admission criteria necessitates that potential participants be between 21 and 65 years old. Simultaneously, 33 studies are available for underage persons and 249 for the elderly."
How many participants are being enrolled in this clinical research?
"Confirmed. According to clinicaltrials.gov, this medical experiment was first made public on April 1st 2022 and is still actively recruiting participants at a single site. A total of 16 individuals need to be enrolled in the study."
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