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New treatment option for Alcohol Use Disorder
Official title Non-invasive Vagal Nerve Stimulation as Novel Treatment to Improve Functional Outcomes in Veterans With Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06399653
What this study is testing
- What it's testing
- Alcohol use disorder (AUD) is a major health concern amongst Veterans as it causes functional impairments and decreased quality of life. Current AUD treatments show limited effectiveness in reducing withdrawal-related psychological and physical distress, which drives the urge to drink to relieve these symptoms.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Veterans between 21 and 65 years, any race or ethnicity.
- Meet current DSM-5 diagnosis of moderate or severe AUD (Structured Clinical Interview for DMS-5 (SCID) interview) with at least one functional...
- Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications.
- Capable of complying with study schedule, procedures, and speaks English.
- Able to provide voluntary written informed consent prior to initiation of visit 1.
You likely can't join if
- Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score \>10 on the day of the scan (symptoms judged to be due to co-existing...
- Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium...
- Currently or recently (within last 90 days) enrolled in abstinence-based treatment program.
- Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit.
- Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD.
- At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical...
See the full eligibility criteria
- Veterans between 21 and 65 years, any race or ethnicity.
- Meet current DSM-5 diagnosis of moderate or severe AUD (Structured Clinical Interview for DMS-5 (SCID) interview) with at least one functional disability due to alcohol use, current alcohol craving, and current heavy...
- Able to forgo consumption of alcohol for 12-24 hours without any serious discomfort or complications.
- Capable of complying with study schedule, procedures, and speaks English.
- Able to provide voluntary written informed consent prior to initiation of visit 1.
- Able and willing to self-administer nVNS/sham stimulation as instructed for the duration of the study, and willing to commit to the return visit at the end of the study.
- Clinical Institute Withdrawal Assessment of Alcohol Scale (CIWA-Ar) score \>10 on the day of the scan (symptoms judged to be due to co-existing anxiety or headache disorders will not be counted toward the total).
- Recent history past 6 months) of severe complications due to alcohol withdrawal (alcohol withdrawal seizures, hallucinations/illusions, delirium tremens).
- Currently or recently (within last 90 days) enrolled in abstinence-based treatment program.
- Evidence of a maladaptive pattern of substance use or abuse other than alcohol one month prior to screening visit.
- Uncontrolled severe psychiatric disorder with psychotic symptoms or cognitive impairment. We will not exclude for PTSD.
- At risk for suicide requiring urgent higher-level care or homicide (based on the Columbia-Suicide Severity Rating Scale and follow-up clinical interview).
- History of neurological disorder that might be associated with cognitive dysfunction.
- History of head trauma involving loss of consciousness \>24 hours
- Clinically significant uncontrolled/unstable medical illness or clinically significant surgery within 1 month of the screening visit.
- MRI-related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body, aortic/aneurysm clips, heart-valve replacement, copper intrauterine device, shunt (ventricular or spinal), neuro/bio-stimulators...
- Vagus nerve stimulation related criteria: active implantable medical device, metallic device implanted at or near the neck, carotid atherosclerosis (narrowing of arteries), cervical vagotomy, clinically significant...
- Pharmacotherapy for AUD: \>= 2 weeks stability is required to ensure a steady state of medication effects prior to nVNS administration.
- Currently taking opioids or benzodiazepines.
- In case it is determined by the investigator during the course of the study, that a subject needs a higher level or care, study participation will be discontinued, and the subject will be excluded from the study.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.