SNPMiner Trials (Home Page)
Report for Clinical Trial NCT03244592
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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.
NCT03244592 Alcohol Use Disorder Inflammation Neurocognitive Dysfunction Craving Alcohol Drinking MeSH:Inflammation Alcoholism Alcohol Drinking Cognitive Dysfunction
HPO:Cognitive impairment Mental deterioration
2 Interventions
Name: Minocycline
Name: Sugar pill
Primary Outcomes
Description: Level of [11C]DAA1106 binding during PET imaging
Measure: Microglial Activation Time: Change from baseline after 28 days of medication dosingDescription: Alcohol Urge Questionnaire (AUQ)
Measure: Cue-Induced Alcohol Craving Time: Change from baseline after 28 days of medication dosingDescription: Total drinks consumed
Measure: Alcohol consumption Time: Day 28 of medication dosing periodDescription: Hopkins Verbal Learning Test
Measure: Verbal Learning and Memory Time: Change from baseline after 28 days of medication dosingDescription: Wisconsin Card Sorting Test
Measure: Set-Shifting Time: Change from baseline after 28 days of medication dosingDescription: Stop Signal Task
Measure: Response Inhibition Time: Change from baseline after 28 days of medication dosingDescription: Grooved Pegboard Test
Measure: Manipulative Dexterity Time: Change from baseline after 28 days of medication dosingDescription: Digit Symbol Substitution Test
Measure: Executive Function Time: Change from baseline after 28 days of medication dosingDescription: Digit Span
Measure: Memory Time: Change from baseline after 28 days of medication dosingDescription: WAIS Vocabulary
Measure: Vocabulary Time: Change from baseline after 28 days of medication dosingDescription: Rey Complex Figure Copy
Measure: Executive Function Time: Change from baseline after 28 days of medication dosingSecondary Outcomes
Description: Serum level of cytokines and innate immune receptors
Measure: Peripheral Proinflammatory Marker levels Time: At baseline (day zero) and after 7, 14, and 21 and 28 days of medication dosingDescription: Symptom count from the alcohol module for the Structured Clinical Interview for DSM-5
Measure: Alcohol Use Disorder Severity Time: At baseline (day zero) and after 28 days of medication dosingPurpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 rs6971
15. low affinity rs6971 genotype Inclusion Criteria: 1. Ages 25 - 45 2. Meet DSM-5 diagnostic criteria for an AUD [n.b., only participants with moderate or severe AUD will be enrolled] 3. Drink ≥ 48 standard drinks in a 30-day period before enrollment Exclusion Criteria: 1. Currently in treatment for AUD, a history of treatment in the 30 days before enrollment, or currently treatment seeking 2. Current (last 12 months) DSM-V diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine 3. Lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder 4. Positive urine screen for narcotics, amphetamines, or sedative hypnotics 5. Serious alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised 6. Pregnancy, nursing, or refusal to use reliable method of birth control (if female) 7. A medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes) 8. AST, ALT, or GGT ≥ 3 times upper normal limit 9. Attempted suicide in the past 3 years and/or serious suicidal intention or plan within the past year 10.
15. low affinity rs6971 genotype Alcohol Use Disorder Inflammation Neurocognitive Dysfunction Craving Alcohol Drinking Inflammation Alcoholism Alcohol Drinking Cognitive Dysfunction 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.