Alcohol Use DisorderPhase 1/2NCT03244592
Minocycline for Alcohol Use Disorder
A Phase 1/2 study testing Minocycline and Sugar pill in people with Alcohol Use Disorder and Inflammation, run by University of California, Los Angeles.
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 21 to 55 years
- Conditions the study is for
- Alcohol Use Disorder, Inflammation, Neurocognitive Dysfunction
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2018to 1 Mar 2018
- Phase
- Phase 1/2
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 25 - 45
- Meet DSM-5 diagnostic criteria for an AUD [n.b., only participants with moderate or severe AUD will be enrolled]
- Drink ≥ 48 standard drinks in a 30-day period before enrollment
Who cannot join
- Currently in treatment for AUD, a history of treatment in the 30 days before enrollment, or currently treatment seeking
- Current (last 12 months) DSM-V diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Positive urine screen for narcotics, amphetamines, or sedative hypnotics
- Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
- Pregnancy, nursing, or refusal to use reliable method of birth control (if female)
Show all 15Show fewer
- A medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- AST, ALT, or GGT ≥ 3 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 MINO
- Any other circumstances that, in the opinion of the investigators, compromises participant safety.
- Claustrophobia
- Participating in any other research study involving exposure to ionizing radiation in the past year will be excluded if the total cumulative exposure from the past research studies and the current research study would exceed the limits set by the FDA in 21 CFR 361.1. Specifically, the total cumulated dose to the whole body, active blood-forming organs, lens of the eye, and gonads must remain below 5 rems, and the cumulated dose to all other organs must remain below 15 rems. Potential participants who have had exposure to ionizing radiation in the past year will not be allowed to participate if we are unable to obtain proper documentation quantifying the amount of past exposure.
- Presence of a metal device in the body (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate): Those devices could either interfere with the acquisition of the MRI scan of the brain or for whom the MRI scan would pose a potential risk. If participants have a non-removable device in their body, they must acquire and show a document exhibiting the device is MRI-compatible.
- low affinity rs6971 genotype
About this study
Official title: Development of Minocycline as a Neuroimmune Therapy for 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 advance medication development for AUD by conducting a randomized, double blind, placebo-controlled, neuroimaging study to examine the effects of minocycline on neuroinflammation, alcohol cue reactivity, neurocognitive performance, and alcohol use. In the proposed study, non-treatment seeking individuals with a current DSM-5 AUD diagnosis (N = 32) will be randomized to receive either 200 mg of minocycline per day or placebo for 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 28 days. Within each laboratory session, participants will complete a cue reactivity paradigm, neurocognitive performance tasks, and a positron emission tomography (PET) imaging session. Neuroinflammation will be assessed by using PET imaging with the radiotracer N-(2,5-dimethoxy-benzyl)-N-(5-fluoro-2-phenoxyphenyl) acetamide, labeled with carbon-11 ([11C]-DAA1106), which binds to the mitochondrial translocator protein, a marker of activated microglia in brain. Additionally, blood samples will be drawn on days 0, 7, 14, 21, and 28 to measure circulating levels of proinflammatory markers and alcohol use over the four weeks of treatment will also be measured.
- Being tested
- Minocycline, Sugar pill
- Keywords
- Minocycline
- Medical subject headings
- Alcoholism, Inflammation, Cognition Disorders, Alcohol Drinking, cyclopia sequence
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 |
|---|---|---|
| Minocycline | Active comparator | 200 mg/day Receives: Drug: Minocycline |
| Sugar Pill | Placebo comparator | Matched placebo Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microglial Activation
Level of [11C]DAA1106 binding during PET imaging
Measured: Change from baseline after 28 days of medication dosing
Cue-Induced Alcohol Craving
Alcohol Urge Questionnaire (AUQ)
Measured: Change from baseline after 28 days of medication dosing
Alcohol consumption
Total drinks consumed
Measured: Day 28 of medication dosing period
Verbal Learning and Memory
Hopkins Verbal Learning Test
Measured: Change from baseline after 28 days of medication dosing
Set-Shifting
Wisconsin Card Sorting Test
Measured: Change from baseline after 28 days of medication dosing
Response Inhibition
Stop Signal Task
Measured: Change from baseline after 28 days of medication dosing
Manipulative Dexterity
Grooved Pegboard Test
Measured: Change from baseline after 28 days of medication dosing
Executive Function
Digit Symbol Substitution Test
Measured: Change from baseline after 28 days of medication dosing
Memory
Digit Span
Measured: Change from baseline after 28 days of medication dosing
Vocabulary
WAIS Vocabulary
Measured: Change from baseline after 28 days of medication dosing
Executive Function
Rey Complex Figure Copy
Measured: Change from baseline after 28 days of medication dosing
Secondary outcomes (2)
Peripheral Proinflammatory Marker levels
Serum level of cytokines and innate immune receptors
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start15 Jan 2018 (estimated)
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Why it stopped: Investigator left institution prior to enrollment of study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Daniel Roche, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244592
- Sponsor's protocol ID
- K01AA026005
- Other IDs
- K01AA026005
- Status last verified
- Jan 2019
- First submitted
- 28 Jul 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Minocycline as a Neuroimmune Therapy for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT03244592
- Acronym / sponsor ID
- K01AA026005
- Keywords
- Minocycline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left institution prior to enrollment of study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 9 Aug 2017 (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 advance medication development for AUD by conducting a randomized, double blind, placebo-controlled, neuroimaging study to examine the effects of minocycline on neuroinflammation, alcohol cue reactivity, neurocognitive performance, and alcohol use. In the proposed study, non-treatment seeking individuals with a current DSM-5 AUD diagnosis (N = 32) will be randomized to receive either 200 mg of minocycline per day or placebo for 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 28 days. Within each laboratory session, participants will complete a cue reactivity paradigm, neurocognitive performance tasks, and a positron emission tomography (PET) imaging session. Neuroinflammation will be assessed by using PET imaging with the radiotracer N-(2,5-dimethoxy-benzyl)-N-(5-fluoro-2-phenoxyphenyl) acetamide, labeled with carbon-11 ([11C]-DAA1106), which binds to the mitochondrial translocator protein, a marker of activated microglia in brain. Additionally, blood samples will be drawn on days 0, 7, 14, 21, and 28 to measure circulating levels of proinflammatory markers and alcohol use over the four weeks of treatment will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Active comparator | Drug: Minocycline200 mg/day |
| Sugar Pill | Placebo comparator | Drug: Sugar pillMatched placebo |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 25 - 45
- Meet DSM-5 diagnostic criteria for an AUD [n.b., only participants with moderate or severe AUD will be enrolled]
- Drink ≥ 48 standard drinks in a 30-day period before enrollment
Key exclusion criteria (15 listed)
- Currently in treatment for AUD, a history of treatment in the 30 days before enrollment, or currently treatment seeking
- Current (last 12 months) DSM-V diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Positive urine screen for narcotics, amphetamines, or sedative hypnotics
- Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised
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 | Minocycline |
| Sugar pillAlso: PlaceboMatched placebo | Drug | Sugar Pill |
Primary outcome
Microglial Activation
Time frame: Change from baseline after 28 days of medication dosing
Level of [11C]DAA1106 binding during PET imaging
Cue-Induced Alcohol Craving
Time frame: Change from baseline after 28 days of medication dosing
Alcohol Urge Questionnaire (AUQ)
Alcohol consumption
Time frame: Day 28 of medication dosing period
Total drinks consumed
Verbal Learning and Memory
Time frame: Change from baseline after 28 days of medication dosing
Hopkins Verbal Learning Test
Set-Shifting
Time frame: Change from baseline after 28 days of medication dosing
Wisconsin Card Sorting Test
Response Inhibition
Time frame: Change from baseline after 28 days of medication dosing
Stop Signal Task
Manipulative Dexterity
Time frame: Change from baseline after 28 days of medication dosing
Grooved Pegboard Test
Executive Function
Time frame: Change from baseline after 28 days of medication dosing
Digit Symbol Substitution Test
Memory
Time frame: Change from baseline after 28 days of medication dosing
Digit Span
Vocabulary
Time frame: Change from baseline after 28 days of medication dosing
WAIS Vocabulary
Executive Function
Time frame: Change from baseline after 28 days of medication dosing
Rey Complex Figure Copy
2 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
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Environment and Alcohol: A Pilot Study
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Cannabidiol as an Adjunct Treatment for Alcohol Withdrawal and Craving
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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 California, Los Angeles
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Minocycline and Sugar pill in people with Alcohol Use Disorder and Inflammation, run by University of California, Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Microglial Activation (time frame: Change from baseline after 28 days of medication dosing). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2019.