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Antibiotic

Alcohol and Neuroimaging Study

Phase 1
Recruiting
Led By Daniel Roche, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 1 day
Treatment 4 weeks
Follow Up at baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing
Awards & highlights

Study Summary

This trial will test whether minocycline, a neuroimmune modulator, can help treat alcohol use disorder. The 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.

Eligible Conditions
  • Disease
  • Cognitive Impairment
  • Cognitive Disorders
  • Neurocognitive Disorder
  • Minocycline
  • Antibiotics
  • Alcohol Use Disorder
  • Alcoholism
  • Pathology
  • Substance Use Disorders
  • Inflammation
  • Chemically-Induced Disorders
  • Psychiatric Disorder
  • Alcohol Consumption

Timeline

Screening ~ 1 day
Treatment ~ 4 weeks
Follow Up ~at baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing
This trial's timeline: 1 day for screening, 4 weeks for treatment, and at baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol consumption
Attention
Cue-Induced Alcohol Craving
+8 more
Secondary outcome measures
Alcohol Use Disorder Severity
Gut microbiota
Peripheral Proinflammatory Marker levels

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Healthy Control-MinocyclineActive Control1 Intervention
Healthy control participants will be randomly assigned to take minocycline for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.
Group II: AUD-MinocyclineActive Control1 Intervention
Participants diagnosed with alcohol use disorder will be randomly assigned to take minocycline for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.
Group III: AUD-PlaceboPlacebo Group1 Intervention
Participants diagnosed with alcohol use disorder will be randomly assigned to take placebo for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.
Group IV: Healthy Control-PlaceboPlacebo Group1 Intervention
Healthy control participants will be randomly assigned to take placebo for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
687 Previous Clinical Trials
374,574 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
799 Previous Clinical Trials
1,362,439 Total Patients Enrolled
Daniel Roche, PhD3.428 ReviewsPrincipal Investigator - University of Maryland School of Medicine
University of Maryland, Baltimore
3 Previous Clinical Trials
23 Total Patients Enrolled
5Patient Review
I had a great experience.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the application process for this trial accessible at present?

"Data on clinicaltrials.gov indicates that this medical trial is actively seeking participants, which it first posted for recruitment on February 3rd 2020 and last updated November 29th 2022."

Answered by AI

What is the capacity of this experimentation in terms of participants?

"Affirmative. The information on clinicaltrials.gov states that this investigation, which was initially announced on February 3rd 2020, is actively enrolling patients. Approximately 72 individuals must be enlisted from a single medical facility."

Answered by AI

Are individuals over the age of eighty-five eligible to participate in this experiment?

"The lower limit for eligibility in this trial is 25 years old, with the upper boundary set at 65."

Answered by AI

What medical ailments is Healthy Control-Minocycline typically used to alleviate?

"Healthy Control-Minocycline is a popular treatment for rocky mountain spotted fever, and has been used to treat various other medical conditions such as q fever, dental root planing, and respiratory tract infections."

Answered by AI

May I partake in this research endeavor?

"This investigation is searching for 72 volunteers aged 25 to 65 who are currently struggling with substance misuse. In addition, the following criteria must be met: men and women should consume a minimum of 14 and 7 alcoholic beverages respectively within 30 days prior to enrollment; heavy drinking (5+ drinks for males/4+ drinks for females) on at least 5 occasions each month; diagnosis of an Alcohol Use Disorder as outlined in DSM-V."

Answered by AI

Has Healthy Control-Minocycline been granted a regulatory endorsement by the FDA?

"Our research team considers Healthy Control-Minocycline to be relatively safe, ranking it a 1 on our scale of 1-3. This determination is based on the limited data available from this Phase I trial regarding efficacy and safety."

Answered by AI

Has there been any precedent of employing Healthy Control-Minocycline in other clinical experiments?

"Currently, 21 medical studies are examining the efficacy of Healthy Control-Minocycline. 6 trials have reached Phase 3 status while dozens of clinical trial sites across 37 cities in Guangzhou, Guangdong test this treatment."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Maryland
What site did they apply to?
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0

What questions have other patients asked about this trial?

How long do screening visits take? Do you reimburse for travel and compensate?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I want to clean my system. I'm tired of drinking and want to stop. I’m hoping to reduce my alcohol dependence.
PatientReceived no prior treatments
Would like to try to reduce my alcohol consumption.
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
Most responsive sites:
  1. Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP): < 48 hours
Recent research and studies
clinicaltrials.govStudy
Neuroimmune Dysfunction in Alcohol Use Disorder
Daniel Roche 2020. "Neuroimmune Dysfunction in Alcohol Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04210713.
~14 spots leftby Apr 2025
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