Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Maryland, Baltimore
Age
21–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ages 21-65
Meet DSM-5 diagnostic criteria for AUD of any severity (Mild, Moderate, or Severe)
You may not be if
Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders and bipolar and related disorders
Positive urine toxicology screen for the following substances: cocaine, opiates, amphetamines, methamphetamine, phencyclidine, barbiturates, benzodiazepine, methadone, and tricyclic antidepressants
Self-reported daily use of opioids (including prescribed)
Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
If female: pregnant, nursing, or with reproductive potential who refuses to use reliable methods of birth control throughout the study
Any autoimmune disorder, inflammatory disorder, or medical condition that may interfere with safe study participation and/or study aims (e.g., any cardiac, renal, or liver disease, uncontrolled hypertension, or diabetes)
Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year
Currently on prescription medication that contraindicates use of diclofenac, including but not necessarily limited to: oral corticosteroids, anticoagulants, lithium, warfarin, aspirin (daily use), methotrexate, cyclosporine, ACE-inhibitors, and diuretics like furosemide and thiazides
Previously known hypersensitivity, including gastroenteritis, asthma, and allergic-type reactions, to any NSAID and/or aspirin
Current daily use of any NSAID or regular pattern of near daily use within the past three months, regular use of a prebiotic or probiotic supplement and/or any antibiotic, prebiotic, or probiotic use within the last month
Any lifetime history of ulcer disease, gastritis, gastroenteritis, or gastrointestinal bleeding
Current or recent (within 3 months) participation in a clinical trial involving medication administration
Currently in treatment, a history of treatment within the 30 days before enrollment, or currently seeking immediate treatment for AUD
Current (last 12 months) DSM-5 diagnosis of SUD for any psychoactive substances other than alcohol and nicotine
Currently prescribed a psychotropic medication for the treatment of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders
AST and ALT \> four times the upper limit of the normal range, or albumin, GFR, BUN, or creatinine 15% \> the upper limit of the normal range
Suffered a mild or moderate traumatic brain injury (TBI) within the last 12 months, a severe TBI at any point in their life, or a moderate TBI before the age of 12
Has below a 6th grade reading level
Within the last 3 months, tested positive for COVID-19 (i.e. the SARS-CoV-2 virus) and experienced common related symptoms
Any other circumstances that, in the opinion of the investigators, compromises participant safety, ability of the investigators to conduct the study as designed, and/or study integrity
