Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Veterans aged between 21 and 65 years, of any race or ethnicity
• People who have been diagnosed with moderate or severe alcohol use disorder (AUD) according to standard diagnostic criteria, confirmed through a structured interview
• People who have at least one area of daily life affected by alcohol use, currently experience cravings for alcohol, and have been drinking heavily (5 or more drinks in a day for men, or 4 or more drinks in a day for women, on 5 or more days in the past month)
• People who experience mild to moderate withdrawal symptoms when they stop drinking
• People who are able to go without alcohol for 12 to 24 hours without serious discomfort or medical complications
• People who are able to follow the study schedule and procedures, and who speak English
• People who are able to give written consent to participate before the study begins
• People who are willing and able to use the study device (a non-invasive nerve stimulator or a sham version) as instructed throughout the study, and who are willing to attend a final return visit

Who may not be able to join:

• People who show moderate to severe alcohol withdrawal symptoms on the day of the brain scan, based on a standard assessment tool
• People who have had serious alcohol withdrawal complications in the past 6 months, such as seizures, hallucinations, or a condition called delirium tremens
• People who are currently enrolled in, or have been enrolled in, an abstinence-based treatment program within the last 90 days
• People who have shown a pattern of misusing substances other than alcohol in the month before screening
• People who have a severe, uncontrolled psychiatric condition involving psychotic symptoms or significant difficulty with thinking and memory (note: a diagnosis of PTSD alone would not exclude someone)
• People who are assessed as being at urgent risk of harming themselves or others
• People who have a known neurological condition that may affect memory or thinking
• People who have had a head injury involving more than 24 hours of unconsciousness
• People who have a significant uncontrolled or unstable medical illness, or who have had major surgery within 1 month of the screening visit
• People who are unable to have an MRI scan due to having a pacemaker, certain metal implants or fragments in the body, certain types of medical devices (such as a heart valve replacement or a spinal shunt), a copper intrauterine device (IUD), or who are pregnant or breastfeeding (all implants will be reviewed for safety)
• People who have certain conditions or devices that make the neck nerve stimulation unsafe, including an implanted medical device, a metallic implant at or near the neck, significant narrowing of the carotid arteries, a history of a surgical procedure on the vagus nerve, uncontrolled blood pressure or heart rate problems, severe heart or cardiovascular disease, a history of stroke or mini-stroke (TIA), heart failure, severe coronary artery disease, or a heart attack within the past 5 years
• People who are taking medication for alcohol use disorder must have been on a stable dose for at least 2 weeks before taking part
• People who are currently taking opioids or benzodiazepines (a type of sedative or anxiety medication)
• People who, during the study, are found by the research team to need a higher level of medical or psychiatric care

Important: Always verify eligibility with the trial site directly before applying.