CompletedPhase 1

Neuroimmune Dysfunction in Alcohol Use Disorder

United States142 participantsStarted 2020-02-03

Plain-language summary

The objective of this proposal is to advance medication development for alcohol use disorder by examining the efficacy and mechanisms of action of minocycline, a neuroimmune modulator, as a potential treatment. This study has important clinical implications, as the available treatments for alcohol use disorder are only modestly effective and testing novel medications is a high research priority.

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

AUD Group Inclusion Criteria: * Meet DSM-5 diagnostic criteria for an AUD * In the 30-day period before enrollment, consume ≥ 14 and ≥ 7 standard drinks per week for men and women, respectively, AND * In the 30-day period before enrollment, engage in heavy drinking (5 or more drinks for men, 4 or more drinks for women) and ≥ 5 times per month AUD Group Exclusion Criteria: * Currently in treatment for AUD, a history of treatment within the 30 days before enrollment, or currently seeking immediate treatment * Current (last 12 months) DSM-5 diagnosis of substance use disorder 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, depressive disorders, anxiety disorders, and mood disorders. * 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 cannabidiol (CBD) or opioids (including prescribed) * Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised * If female: pregnancy, nursing, or refusal to use reliable method of birth control; if using hormonal …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neuroinflammation

Timeframe: Change from baseline after 28 days of medication dosing

Cue-Induced Alcohol Craving

Timeframe: Change from baseline after 28 days of medication dosing

Alcohol consumption

Timeframe: Change from baseline after 28 days of medication dosing

Verbal Fluency/Language

Timeframe: Change from baseline after 28 days of medication dosing

Speed of processing

Timeframe: Change from baseline after 28 days of medication dosing

Speed of processing

Timeframe: Change from baseline after 28 days of medication dosing

Speed of processing

Timeframe: Change from baseline after 28 days of medication dosing

Trial details

NCT IDNCT04210713

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-20

View on ClinicalTrials.gov More Alcohol Drinking trials

Plain-language summary

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neuroinflammation

Timeframe: Change from baseline after 28 days of medication dosing

Cue-Induced Alcohol Craving

Timeframe: Change from baseline after 28 days of medication dosing

Alcohol consumption

Timeframe: Change from baseline after 28 days of medication dosing

Verbal Fluency/Language

Timeframe: Change from baseline after 28 days of medication dosing

Speed of processing

Timeframe: Change from baseline after 28 days of medication dosing

Speed of processing

Timeframe: Change from baseline after 28 days of medication dosing

Speed of processing

Timeframe: Change from baseline after 28 days of medication dosing