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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

Description: 200 mg/day

Type: Drug

Minocycline

Name: Sugar pill

Description: Matched placebo

Type: Drug

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 dosing

Description: Alcohol Urge Questionnaire (AUQ)

Measure: Cue-Induced Alcohol Craving

Time: Change from baseline after 28 days of medication dosing

Description: Total drinks consumed

Measure: Alcohol consumption

Time: Day 28 of medication dosing period

Description: Hopkins Verbal Learning Test

Measure: Verbal Learning and Memory

Time: Change from baseline after 28 days of medication dosing

Description: Wisconsin Card Sorting Test

Measure: Set-Shifting

Time: Change from baseline after 28 days of medication dosing

Description: Stop Signal Task

Measure: Response Inhibition

Time: Change from baseline after 28 days of medication dosing

Description: Grooved Pegboard Test

Measure: Manipulative Dexterity

Time: Change from baseline after 28 days of medication dosing

Description: Digit Symbol Substitution Test

Measure: Executive Function

Time: Change from baseline after 28 days of medication dosing

Description: Digit Span

Measure: Memory

Time: Change from baseline after 28 days of medication dosing

Description: WAIS Vocabulary

Measure: Vocabulary

Time: Change from baseline after 28 days of medication dosing

Description: Rey Complex Figure Copy

Measure: Executive Function

Time: Change from baseline after 28 days of medication dosing

Secondary 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 dosing

Description: 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 dosing

Purpose: 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.



HPO Nodes


HPO:
Cognitive impairment
Genes 850
PRNP GRN POMT2 WDR45 RNASEH1 PRKAR1A TRNS2 SCN1A CYP27A1 ATXN3 ATP1A3 OPA1 SNCA QDPR TRNS1 APOL4 PORCN CTC1 CTSH SNORD118 DRD3 SCN9A ADH1C LZTFL1 MTFMT GPC4 POMT2 APOE RMRP LMNB1 SCN1A GABRA2 AP5Z1 SDHD TIMMDC1 PNKP SNCA YWHAG ADGRV1 SLC25A4 GBA POLG PSAP APOL2 SCN3A DNAJC6 SYN2 RAB27A HTT CENPE ERCC4 SUMF1 ITGA7 CAMTA1 GABRG2 SPG7 KRT17 SDHA ALOX12B GBA2 WFS1 TYROBP RRM2B NPC2 CEP120 CEP152 ERCC6 ALG2 SPG7 AIFM1 MEN1 BBS5 SCARB2 SOST DMD TMEM240 CNTNAP2 TRNF HTT PDGFRB UCHL1 PTPN22 PRNP HNRNPA2B1 LRRK2 TNFSF4 CYTB MFSD8 TINF2 PEX5 APP COASY ATP13A2 PSEN1 IL10 PTEN SCN2A HLA-DQB1 C12ORF65 ATXN3 NOTCH3 BMPR1A GBE1 AP2M1 CFH JPH3 SUFU TTR PODXL VAMP1 SULT2B1 PRNP GJC2 LARGE1 ND5 CTSD POLG SDR9C7 GRN KRT6B SDHAF1 PRKCG TP53RK ATP6V0A2 NFIA GRN TMEM106B SIM1 PEX2 PMS2 MATR3 PRNP MAPT MAPT ERCC2 COL18A1 MAPT CYP4F22 C19ORF12 MTHFR POLG CCDC78 LAGE3 C1R OCRL GDNF DSG4 CLN8 PRKN CACNA1B GNAS XRCC4 MSH2 ATN1 FA2H PLAU B3GALNT2 SLC2A1 CENPJ VCP PANK2 NDUFB8 PEX11B GJC2 TRAK1 RPS20 SYNGAP1 HNRNPA2B1 TP53 FGF14 TBP COL1A1 SYNJ1 MATR3 POLG WWOX GABRB2 PSAP ABCA7 BBS10 KCNA2 ALDH18A1 KMT2B FTL COX3 TMEM106B NUS1 FGF12 TGFBR2 PSEN2 TWNK HLA-B FBXO7 COX2 LRRK2 BBS12 EEF1A2 RRM2B FMR1 PRKAR1B IFT140 NTRK2 ND5 POLG HEPACAM C12ORF65 GLA SPG21 GRID2 CTSK GNAS CLTC ERCC3 ADAMTSL4 EPM2A PDGFRB SYNJ1 GBA ATXN2 COL5A2 NPHP1 REEP2 DHDDS RTN4R NRAS ABCA5 CCR1 SLC2A1 SCN8A MYH3 KCNA2 TREM2 TREM2 CLN8 POMGNT1 GNAS STX1B PLA2G6 PLA2G6 COQ2 SUMF1 TARDBP GSN ATRIP TWNK TRNQ NDP PINK1 MFN2 STAT4 CCM2 NHLRC1 VPS13C CRLF1 ATXN7 ABCA12 PSAP PTS FA2H SCN1B PEX3 TRNK MAPT GBE1 RBM28 PDE10A KCTD7 ACTB MAPT RAB39B TREM2 SNCA WDR4 MAPT TARDBP CLN6 MYD88 CLMP DNM1 ATP1A2 UBAP1 TRNW PANK2 CLCF1 ATP6 GBA2 TRNE TMEM106B MAPT OSGEP PDGFB EIF2B3 SNCA JPH3 SMC1A NAGS C9ORF72 NAGLU APTX SLC25A4 PDGFB ROGDI PRDM8 UQCRC2 IL23R C19ORF12 ATXN10 ALG12 PLEKHG4 MLH3 ND6 HTRA2 LIPN NKX6-2 FGFR3 RNASEH1 TMEM240 ATP13A2 TRNF DCC TRNL1 EPRS1 CUBN PRNP NBN ATP1A3 TLR3 GBA KCNQ3 NAGS POMT1 TGM1 SLC13A5 SLC30A9 KRT86 POLG2 SNCB NF2 ATP6V1A AP3B2 UCP2 AFG3L2 PEX13 DCTN1 ERAP1 PRNP PRNP RBM12 MSH6 MAPT ARV1 TTC8 PEX12 KRT83 TBK1 DGUOK LTBP4 TPRKB ARSA CHMP2B FKRP SPG11 PSEN2 CISD2 SCN8A ATXN1 CHRM3 ATXN7 FTL CYP2U1 HCN1 AKT1 KMT2A PPP2R2B STUB1 KIF5A TBK1 CHMP2B TYROBP ERCC5 HLA-DRB1 EPM2A ITPR1 PEX16 ND1 GABRD GABRA5 PNKP ABCA7 SDHA ADD3 EDN3 VAMP1 SEMA4A PIK3CA XPA UBAC2 SDHB ATR FGD1 C4A PDCD10 DARS2 CNKSR2 FA2H CTNS NIPAL4 KCNJ11 CLN5 MEFV SYNJ1 PHOX2B FKTN TBP APP RIN2 ATP6V1A ERCC8 GBA VCP XPC DNM1 MMACHC A2M TBK1 TUBB2B DISC2 ITPR1 ATN1 RRM2B VCP TIMM8A SCN9A GMPPB CSF1R CTDP1 CHMP2B SLC6A1 DNAJC13 ND1 RBBP8 PARS2 TYMP FGF14 GABRB3 BSCL2 CPLX1 TSC1 FUS ERCC4 COX2 SCN1A GJB6 TRNQ POMK IRF6 UBA5 PEX19 LAMA2 DNMT1 HNRNPA1 MTO1 KRT81 SMC3 DNMT1 PDE11A ITM2B ATP6V1E1 COX3 HEXB KCNQ2 C9ORF72 GCDH SURF1 PNPLA6 NHLRC1 DAOA C9ORF72 SLC7A7 SDHD C9ORF72 UBTF RNF216 KCNT1 BRAF METTL23 NDUFS2 MOG ATP13A2 APP CLN3 ND5 COL5A1 ASAH1 KRT6A SNCAIP BSCL2 DCAF17 STXBP1 IL12A-AS1 TSC1 GALC ATP6 IDUA ZNF365 HSD17B10 PPT1 MEOX1 PSEN1 MYO1H TSFM TRNK TTC19 AUH PSEN1 APP GNAS COX1 APP GJB2 COASY SPG11 PRNP ATP13A2 POLG DCTN1 CHMP2B PPP2R2B SRCAP HEXA CST3 TWNK PEX14 XPA SNCA SMARCB1 CSF1R TRNH ATG5 PEX10 CHMP2B AMN KCNQ2 GABRG2 APP CSTB TRNK TRNL1 PSEN1 SLC25A15 CP UBQLN2 TREM2 TSC2 VPS13A KRIT1 KRAS ARSA NR4A2 PRDM8 VCP RBM28 PSEN1 SDCCAG8 CACNA1G PINK1 TRPM7 CFAP43 SPP1 HFE TRNS1 ALG13 GBA TK2 ATP7B INSR NDUFA6 XPR1 TUBA4A AKT1 CHD2 SDHAF1 CERS1 AARS2 CTSF GDF5 SERPINI1 TRNL1 VPS37A ATXN1 SCN2A HSD17B4 COX1 MAPT SLC5A7 TRNC SPG11 NOTCH3 MAPK10 CENPJ PLP1 P2RY11 GRN TRNW CHCHD10 TTPA VCP DOLK C1QA C9ORF72 GDF6 TIMM8A TSC2 GMPPB KLRC4 PLK4 TRNP ALG9 B3GALNT2 GDF3 HIBCH STARD7 PANK2 CUX2 PLAA ECM1 ACSF3 PDGFRB CHI3L1 MAPT ERF EIF4G1 VPS35 TREX1 COL3A1 ALDH18A1 CHD2 PRDX1 PRICKLE1 WDR73 HCN1 SLC13A5 ZFYVE26 POLG AFG3L2 HNF1A GM2A TBP HTR2A SQSTM1 WFS1 AASS ND4 ERCC2 KCNQ3 SPAST PRKCG NDUFAF3 RNF216 GRID2 CHRNG SLC25A13 EIF2B2 CLN6 KCND3 GDAP2 GBA PSEN1 HTRA1 SEC61A1 IBA57 FAN1 FAS NECAP1 PRKRA PEX16 ND6 PANK2 DNAJC3 GLUD2 GCH1 LRRK2 ERCC3 MECP2 FLNA NOS3 UBA1 SQSTM1 ATXN2 ARSA MTOR SQSTM1 GRN APP NOTCH2NLC PDGFB TBC1D24 TRNV SCN8A TWNK MAPT TRAIP LAMP2 ROGDI SLC20A2 ABCC8 CTNS TRNH CYFIP2 GRIN2D WDR45 HLA-DQB1 MAOA BRAF SLC18A2 NPC1 GLB1 SMC1A EIF2B1 ROBO3 GBA ATXN3 PEX26 MAPT PARK7 UGT1A1 MYORG SDHD DNM1L SLC1A2 PGM3 IL12A SLC18A2 MAPT TRNQ AP5Z1 PCNT MARS2 DARS2 HGSNAT COL4A1 SLC2A3 DNAJC6 CYP2U1 MBTPS2 TRNF FMR1 PMS1 DGUOK KRT16 TUBB4A CFHR1 EIF2B5 NUP107 TRNS1 BDNF TK2 ALOXE3 SGPL1 AARS1 SDHC TREX1 TTC37 MLH1 TRNS2 MPDU1 KCNC1 PEX1 VPS13C SPART KATNB1 EIF2B4 VCP RRM2B GM2A SORL1 CYP7B1 ABCD1 PLA2G6 HTT DNAJC5 HCRT ARL6IP6 ATXN3 ATP13A2 CSTB TRNS2 STUB1 SPAST PSEN1 PIK3CA CHCHD10 MPO ITM2B CFHR3 SPR FBN1 BBIP1 FAS CACNA1A NAGA MCOLN1 PAH SPG21 TLR4 ADA2 ATM TREM2 STAT4 VPS13A ATXN8OS HNF4A SCO2 SPTBN2 PPP3CA ATXN2 TOMM40 OPA3 GIGYF2 EPCAM KLLN PRNP PEX6 APOE SEC23B SZT2 COMT PRRT2 DSTYK ADA2 SQSTM1 NUP133 ACTL6B ST3GAL5 IRAK1 DDB2 C9ORF72 SDHB KCNB1 CFAP43 DNMT1 RNR1 CP HTRA1 GNE ASAH1 MAG SPTBN2 IKBKG SNCA
Mental deterioration
Genes 462
TIMM8A PRNP GRN SCN9A CSF1R WDR45 RNASEH1 PRKAR1A CHMP2B SCN1A SLC6A1 CYP27A1 ATP1A3 DNAJC13 ND1 OPA1 SNCA QDPR TRNS1 APOL4 CTC1 SNORD118 DRD3 ADH1C PARS2 APOE TYMP GABRB3 BSCL2 CPLX1 FUS LMNB1 ERCC4 GABRA2 AP5Z1 COX2 SCN1A TIMMDC1 SNCA YWHAG TRNQ IRF6 UBA5 GBA DNMT1 PSAP HNRNPA1 APOL2 SCN3A DNAJC6 DNMT1 PDE11A SYN2 ITM2B RAB27A HTT SUMF1 ATP6V1E1 GABRG2 SDHA COX3 GBA2 HEXB WFS1 TYROBP C9ORF72 RRM2B NPC2 SURF1 PNPLA6 NHLRC1 DAOA ERCC6 SCARB2 C9ORF72 CNTNAP2 UBTF HTT RNF216 PDGFRB UCHL1 PRNP HNRNPA2B1 LRRK2 NDUFS2 CYTB MFSD8 TINF2 APP APP CLN3 ATP13A2 PSEN1 ASAH1 ATXN3 SNCAIP BSCL2 DCAF17 NOTCH3 STXBP1 GBE1 AP2M1 GALC ATP6 IDUA HSD17B10 PPT1 JPH3 PSEN1 TTR PODXL PSEN1 APP COX1 PRNP APP COASY CTSD SPG11 GRN PRNP ATP13A2 POLG DCTN1 CHMP2B PPP2R2B SDHAF1 HEXA CST3 TWNK ATP6V0A2 GRN XPA TMEM106B SNCA CSF1R MATR3 PRNP MAPT CHMP2B AMN MAPT ERCC2 COL18A1 APP MAPT CSTB TRNK C19ORF12 MTHFR PSEN1 CP UBQLN2 TREM2 CLN8 PRKN CACNA1B ARSA NR4A2 ATN1 PRDM8 VCP RBM28 PSEN1 FA2H PINK1 PLAU TRPM7 CFAP43 HFE VCP GBA NDUFB8 ATP7B NDUFA6 XPR1 TUBA4A TRAK1 AKT1 SYNGAP1 CHD2 HNRNPA2B1 CERS1 AARS2 CTSF TBP SYNJ1 SERPINI1 MATR3 TRNL1 WWOX GABRB2 MAPT PSAP ABCA7 KCNA2 TRNC ALDH18A1 NOTCH3 MAPK10 PLP1 GRN FTL CHCHD10 TMEM106B TTPA VCP C9ORF72 TIMM8A NUS1 FGF12 PSEN2 FBXO7 LRRK2 HIBCH EEF1A2 PANK2 CUX2 FMR1 PRKAR1B PDGFRB NTRK2 CHI3L1 ND5 MAPT EIF4G1 HEPACAM VPS35 SPG21 GNAS TREX1 CLTC ALDH18A1 EPM2A PDGFRB CHD2 SYNJ1 GBA PRDX1 ATXN2 PRICKLE1 DHDDS RTN4R SLC13A5 ZFYVE26 NRAS POLG SCN8A HNF1A KCNA2 TREM2 TBP HTR2A SQSTM1 WFS1 TREM2 CLN8 PLA2G6 SPAST PRKCG NDUFAF3 RNF216 CLN6 PLA2G6 GDAP2 GBA PSEN1 SUMF1 HTRA1 TARDBP NDP PINK1 MFN2 NECAP1 NHLRC1 VPS13C ATXN7 ND6 PANK2 PSAP GLUD2 PTS GCH1 LRRK2 MECP2 NOS3 FA2H SQSTM1 ATXN2 ARSA TRNK SQSTM1 MAPT GRN APP RBM28 NOTCH2NLC PDGFB TBC1D24 PDE10A KCTD7 TRNV MAPT ACTB MAPT RAB39B TREM2 ROGDI SNCA SLC20A2 MAPT ABCC8 CTNS TARDBP CYFIP2 GRIN2D CLN6 WDR45 DNM1 HLA-DQB1 ATP1A2 UBAP1 TRNW NPC1 ATP6 GLB1 GBA2 TRNE TMEM106B MAPT PDGFB GBA SNCA JPH3 SMC1A MAPT C9ORF72 PARK7 NAGLU APTX MYORG SDHD DNM1L SLC1A2 ROGDI PRDM8 C19ORF12 MAPT ATXN10 PLEKHG4 HTRA2 DARS2 HGSNAT COL4A1 SLC2A3 ATP13A2 MBTPS2 TRNF CUBN FMR1 NBN TLR3 TUBB4A GBA SLC13A5 TK2 SGPL1 AARS1 TREX1 TRNS2 KCNC1 SNCB VPS13C ATP6V1A AP3B2 VCP RRM2B UCP2 DCTN1 GM2A SORL1 PRNP PRNP MAPT ABCD1 ARV1 PLA2G6 TBK1 HTT DNAJC5 DGUOK ARSA ATP13A2 CHMP2B CSTB SPG11 PSEN2 PSEN1 CISD2 CHCHD10 MPO ATXN7 ITM2B FTL HCN1 CACNA1A MCOLN1 PAH SPG21 KMT2A PPP2R2B ADA2 TREM2 TBK1 CHMP2B TYROBP EPM2A VPS13A ATXN8OS HNF4A SCO2 GABRA5 PPP3CA ATXN2 TOMM40 GIGYF2 PRNP APOE SZT2 COMT SDHB ADA2 SQSTM1 ACTL6B ST3GAL5 CNKSR2 FA2H C9ORF72 KCNJ11 CLN5 SYNJ1 TBP KCNB1 CFAP43 APP ATP6V1A ERCC8 GBA VCP DNMT1 DNM1 MMACHC A2M CP HTRA1 TBK1 ASAH1 DISC2 ATN1 RRM2B SNCA VCP