Alcohol DrinkingPhase 1NCT04210713
Neuroimmune Dysfunction in Alcohol Use Disorder
A Phase 1 study testing Minocycline and Sugar pill in people with Alcohol Drinking and Alcohol-Related Disorders, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol-Related Disorders, Disease
- What is being tested?
- Minocycline and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2020to 20 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 contraceptives, refusal to use secondary birth control method
- Any autoimmune or inflammatory medical disorder or medical condition that may interfere with safe study participation and/or study aims (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or γ-glutamyl transferase (GGT) ≥ 4 times upper normal limit
- 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 minocycline, including but not necessarily limited to: isoretinoin, ergot alkaloids, and anti-coagulants.
- Previously known hypersensitivity to tetracyclines
- Current or recent (within one month) treatment with any antibiotic
- Regular use of a prebiotic or probiotic supplement
- Claustrophobia or physical issues preventing MRI scan
- Presence of a metal device in the body (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate)
- Current or recent (within 3 months) participation in a clinical trial involving medication administration
- 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.
- Having 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.
Healthy Control Group Inclusion Criteria:
- Does not meet DSM-5 diagnostic criteria for an AUD (current or lifetime)
- In the 30-day period before enrollment, consume ≤ 14 and ≤ 7 standard drinks per week for men and women, respectively
- Engage in infrequent heavy drinking during the past 6 months (≤ 2 heavy drinking events in past 6 months)
Healthy Control Group Exclusion Criteria:
- Lifetime DSM-5 diagnosis of substance use disorder for any psychoactive substances other than nicotine
- Self-reported daily use of cannabidiol (CBD) or opioids (including prescribed)
- Lifetime DSM-5 diagnosis of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive disorders, anxiety disorders (panic disorder, agoraphobia, social anxiety, and generalized anxiety), obsessive-compulsive and related disorders, trauma- and stressor-related disorders, feeding and eating disorders (binge eating, anorexia, and bulimia), conduct disorders, and gambling disorder
- Positive urine toxicology screen for the following substances: cocaine, opiates, amphetamines, methamphetamine, phencyclidine, barbiturates, benzodiazepine, methadone, and tricyclic antidepressants.
- 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 contraceptives, refusal to use secondary birth control method
- Any autoimmune or inflammatory medical disorder or medical condition that may interfere with safe study participation and/or study aims (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or γ-glutamyl transferase (GGT) ≥ 4 times upper normal limit
- 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 minocycline, including but not necessarily limited to: isoretinoin, ergot alkaloids, and anti-coagulants.
- Previously known hypersensitivity to tetracyclines
- Current or recent (within one month) treatment with any antibiotic
- Regular use of a prebiotic or probiotic supplement
- Claustrophobia or physical issues preventing MRI scan
- Presence of a metal device in the body (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate)
- Current or recent (within 3 months) participation in a clinical trial involving medication administration
- 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.
- Having 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Maryland Psychiatric Research Center (MPRC) Treatment Research Program (TRP)
Catonsville, Maryland, 21228
About this study
Official title: Characterization of Neuroimmune Dysfunction in Alcohol Use Disorder
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.
Read the detailed description
The research objective of this project is to characterize the role of the neuroimmune system in alcohol use disorder (AUD). The proposed study employs a randomized, double-blind, and placebo-controlled design to examine how neuroinflammation, as measured via neuroimaging [e.g., magnetic resonance imaging (MRI)], relates to alcohol craving, neurocognitive impairment (e.g., memory, attention, etc.), and alcohol use in non-treatment seeking individuals with AUD. The study will also determine whether minocycline (MINO), an FDA-approved antibiotic medication, affects any of the above listed measures. In the proposed study, healthy controls (n = 36) and non-treatment seeking individuals with a current Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 AUD diagnosis (n = 36) will be randomized to receive either 200 mg of minocycline per day or placebo for approximately 28 days and complete two laboratory sessions. The first laboratory session will be performed immediately before commencing the medication regimen (day 0) and the second will be completed after taking the medication daily for approximately 28 days. Within each laboratory session, participants will complete a cue reactivity paradigm, neurocognitive performance tasks, and a magnetic resonance imaging (MRI) session. Additionally, blood samples will be drawn on days 0, 7, 14, 21, and 28 of treatment to measure circulating levels of proinflammatory molecules in order to identify the specific immune signaling pathways underlying neuroinflammation in AUD. Clinical labs (e.g., blood chemistry, liver function tests) and adverse events (AEs) will also be assessed at these five visits.
- Conditions
- Alcohol Drinking, Alcohol-Related Disorders, Disease, Inflammation, Alcoholism, Cognitive Dysfunction
- Being tested
- Minocycline, Sugar pill
- Keywords
- Minocycline
- Medical subject headings
- Alcohol Drinking, Alcohol-Related Disorders, Disease, Inflammation, Alcoholism, Cognitive Dysfunction, Pathologic Processes, Drinking Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
200 mg/day
Sugar pillDrug
Also called Placebo
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| AUD-Minocycline | Active comparator | 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. Receives: Drug: Minocycline |
| AUD-Placebo | Placebo comparator | 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. Receives: Drug: Sugar pill |
| Healthy Control-Minocycline | Active comparator | 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. Receives: Drug: Minocycline |
| Healthy Control-Placebo | Placebo comparator | 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. Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroinflammation
A multimodal MRI approach consisting of Diffusion Tensor Imaging (DTI) with free water imaging and Magnetic Resonance Spectroscopy (MRS) will be utilized to assess neuroinflammation
Measured: Change from baseline after 28 days of medication dosing
Cue-Induced Alcohol Craving
Participants will listen to a 5-minute guided cue exposure script, during which they are exposed to both a neutral and their preferred alcoholic beverage. Prior to beginning the paradigm and after each cue exposure participants will rate their alcohol craving using the "Alcohol Urge Questionnaire (AUQ)" and cigarette craving using the "Brief Questionnaire on Smoking Urges (BQSU)." Both scales range from 1 to 7 with higher scores reflecting more craving.
Measured: Change from baseline after 28 days of medication dosing
Alcohol consumption
Total drinks consumed assessed using the Timeline Follow Back
Measured: Change from baseline after 28 days of medication dosing
Verbal Fluency/Language
Wechsler Abbreviated Scale of Intelligence (WASI)-Vocabulary, WASI-Similarities, Verbal Fluency (Animals), with higher scores indicating greater intellectual ability.
Measured: Change from baseline after 28 days of medication dosing
Speed of processing
Brief Assessment of Cognition in Schizophrenia (BACS)-Symbol Coding [scored by number of correct numerals (range: 0 -110)]
Measured: Change from baseline after 28 days of medication dosing
Speed of processing
Trail Making Test: Part A (scored by time to complete test with lower scores being better)
Measured: Change from baseline after 28 days of medication dosing
Speed of processing
Grooved Pegboard (scored as a sum of the total time, total number of drops, and the total number of pegs correctly placed in the board with higher scores corresponding to worse performance)
Measured: Change from baseline after 28 days of medication dosing
Working Memory
Wechsler Memory Scale (WMS)-Spatial Span (scored up to 32 correct series), Letter-Number Span (scored up to 30 correct series)
Measured: Change from baseline after 28 days of medication dosing
Attention
Continuous Performance Test
Measured: Change from baseline after 28 days of medication dosing
Problem Solving/Executive Functioning
Wisconsin Card Sorting Test-64
Measured: Change from baseline after 28 days of medication dosing
Inhibition/Impulsivity
Stop-Signal Reaction Time
Measured: Change from baseline after 28 days of medication dosing
Verbal Learning
Hopkins Verbal Learning Test
Measured: Change from baseline after 28 days of medication dosing
Visual Learning
Brief Visuospatial Memory Test [scoring is as follows, 1) Total recall: The sum of all valid items generated across learning trials 1-3, 2) Delayed recall: The number of valid items generated after a delay (trial 4), 3) Percent retained: Delayed recall score divided by the higher of trial 2 or 3 × 100, and 4) Recognition Discrimination Index: True positive responses minus false positive responses.]
Measured: Change from baseline after 28 days of medication dosing
Secondary outcomes (3)
Peripheral Proinflammatory Marker levels
Serum level of inflammatory molecules
Measured: At baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing
Alcohol Use Disorder Severity
Symptom count from the alcohol module for the Structured Clinical Interview for DSM-5
Measured: At baseline (day zero) and after 28 days of medication dosing
Gut microbiota
Gut microbiota from stool samples using the following parameters: 1) diversity and evenness (Shannon, Simpson index) and 2) similarity (phylogenetic UniFrac distance, Jensen-Shannon divergence)
Measured: At baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start3 Feb 2020
- Primary completion20 Sep 2023
- Study completion20 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Daniel Roche, University of Maryland, Baltimore
- Investigators
- Daniel Roche, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210713
- Sponsor's protocol ID
- HP-00080891
- Other IDs
- 5K01AA026005-03
- Status last verified
- Nov 2023
- First submitted
- 17 Dec 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wheeler PB, Mackey CD, Moskal D, Brady DJ, Foster KT, Marks RM, Dickerson DL, Kelly DL, Bennett ME, Roche DJO. Religiosity and the relationship between sexual trauma, alcohol use, and sleep quality: a moderated mediation model. Alcohol Alcohol. 2025 May 14;60(4):agaf030. doi: 10.1093/alcalc/agaf030.
PubMed 40483726
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Neuroimmune Dysfunction in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT04210713
- Acronym / sponsor ID
- HP-00080891
- Conditions
- Alcohol Drinking, Alcohol-Related Disorders, Disease, Inflammation, Alcoholism, Cognitive Dysfunction
- Keywords
- Minocycline
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 3 Feb 2020 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research objective of this project is to characterize the role of the neuroimmune system in alcohol use disorder (AUD). The proposed study employs a randomized, double-blind, and placebo-controlled design to examine how neuroinflammation, as measured via neuroimaging [e.g., magnetic resonance imaging (MRI)], relates to alcohol craving, neurocognitive impairment (e.g., memory, attention, etc.), and alcohol use in non-treatment seeking individuals with AUD. The study will also determine whether minocycline (MINO), an FDA-approved antibiotic medication, affects any of the above listed measures. In the proposed study, healthy controls (n = 36) and non-treatment seeking individuals with a current Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 AUD diagnosis (n = 36) will be randomized to receive either 200 mg of minocycline per day or placebo for approximately 28 days and complete two laboratory sessions. The first laboratory session will be performed immediately before commencing the medication regimen (day 0) and the second will be completed after taking the medication daily for approximately 28 days. Within each laboratory session, participants will complete a cue reactivity paradigm, neurocognitive performance tasks, and a magnetic resonance imaging (MRI) session. Additionally, blood samples will be drawn on days 0, 7, 14, 21, and 28 of treatment to measure circulating levels of proinflammatory molecules in order to identify the specific immune signaling pathways underlying neuroinflammation in AUD. Clinical labs (e.g., blood chemistry, liver function tests) and adverse events (AEs) will also be assessed at these five visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AUD-Minocycline | Active comparator | Drug: MinocyclineParticipants 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. |
| AUD-Placebo | Placebo comparator | Drug: Sugar pillParticipants 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. |
| Healthy Control-Minocycline | Active comparator | Drug: MinocyclineHealthy control participants will be randomly assigned to take minocycline for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo. |
| Healthy Control-Placebo | Placebo comparator | Drug: Sugar pillHealthy control participants will be randomly assigned to take placebo for 4 weeks. The randomization is double-blinded and will alternate between minocycline and placebo. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline200 mg/day | Drug | AUD-Minocycline, Healthy Control-Minocycline |
| Sugar pillAlso: PlaceboMatched placebo | Drug | AUD-Placebo, Healthy Control-Placebo |
Primary outcome
Neuroinflammation
Time frame: Change from baseline after 28 days of medication dosing
A multimodal MRI approach consisting of Diffusion Tensor Imaging (DTI) with free water imaging and Magnetic Resonance Spectroscopy (MRS) will be utilized to assess neuroinflammation
Cue-Induced Alcohol Craving
Time frame: Change from baseline after 28 days of medication dosing
Participants will listen to a 5-minute guided cue exposure script, during which they are exposed to both a neutral and their preferred alcoholic beverage. Prior to beginning the paradigm and after each cue exposure participants will rate their alcohol craving using the "Alcohol Urge Questionnaire (AUQ)" and cigarette craving using the "Brief Questionnaire on Smoking Urges (BQSU)." Both scales range from 1 to 7 with higher scores reflecting more craving.
Alcohol consumption
Time frame: Change from baseline after 28 days of medication dosing
Total drinks consumed assessed using the Timeline Follow Back
Verbal Fluency/Language
Time frame: Change from baseline after 28 days of medication dosing
Wechsler Abbreviated Scale of Intelligence (WASI)-Vocabulary, WASI-Similarities, Verbal Fluency (Animals), with higher scores indicating greater intellectual ability.
Speed of processing
Time frame: Change from baseline after 28 days of medication dosing
Brief Assessment of Cognition in Schizophrenia (BACS)-Symbol Coding [scored by number of correct numerals (range: 0 -110)]
Speed of processing
Time frame: Change from baseline after 28 days of medication dosing
Trail Making Test: Part A (scored by time to complete test with lower scores being better)
Speed of processing
Time frame: Change from baseline after 28 days of medication dosing
Grooved Pegboard (scored as a sum of the total time, total number of drops, and the total number of pegs correctly placed in the board with higher scores corresponding to worse performance)
Working Memory
Time frame: Change from baseline after 28 days of medication dosing
Wechsler Memory Scale (WMS)-Spatial Span (scored up to 32 correct series), Letter-Number Span (scored up to 30 correct series)
Attention
Time frame: Change from baseline after 28 days of medication dosing
Continuous Performance Test
Problem Solving/Executive Functioning
Time frame: Change from baseline after 28 days of medication dosing
Wisconsin Card Sorting Test-64
Inhibition/Impulsivity
Time frame: Change from baseline after 28 days of medication dosing
Stop-Signal Reaction Time
Verbal Learning
Time frame: Change from baseline after 28 days of medication dosing
Hopkins Verbal Learning Test
Visual Learning
Time frame: Change from baseline after 28 days of medication dosing
Brief Visuospatial Memory Test [scoring is as follows, 1) Total recall: The sum of all valid items generated across learning trials 1-3, 2) Delayed recall: The number of valid items generated after a delay (trial 4), 3) Percent retained: Delayed recall score divided by the higher of trial 2 or 3 × 100, and 4) Recognition Discrimination Index: True positive responses minus false positive responses.]
3 secondary outcomes
Peripheral Proinflammatory Marker levels
Time frame: At baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing
Alcohol Use Disorder Severity
Time frame: At baseline (day zero) and after 28 days of medication dosing
Gut microbiota
Time frame: At baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 40483726Wheeler PB, Mackey CD, Moskal D, Brady DJ, Foster KT, Marks RM, Dickerson DL, Kelly DL, Bennett ME, Roche DJO. Religiosity and the relationship between sexual trauma, alcohol use, and sleep quality: a moderated mediation model. Alcohol Alcohol. 2025 May 14;60(4):agaf030. doi: 10.1093/alcalc/agaf030.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Roche, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocycline and Sugar pill in people with Alcohol Drinking and Alcohol-Related Disorders, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroinflammation (time frame: Change from baseline after 28 days of medication dosing). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.