SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00453609

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI): An Open Prospective Pilot Trial

The overall goal of this project is to improve the treatment of alcohol dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I or type II disorder. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI. SUD comorbidity is associated with many adverse consequences. However, to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with SMI. The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone in reducing alcohol use from baseline levels.

NCT00453609 Schizophrenia Schizoaffective Disorder Bipolar Disorder Alcohol Dependence
MeSH: Disease Schizophrenia Bipolar Disorder Psychotic Disorders Alcoholism Mental Disorders
HPO: Bipolar affective disorder Mania Psychosis Schizophrenia

1 Interventions

Name: long-lasting injectable naltrexone

Type: Drug


Primary Outcomes

Measure: feasibility: number recruited, visits attended

Secondary Outcomes

Measure: genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1)

Measure: alcohol use: self-report, biological measures, level of craving.

Measure: psychiatric functioning

Measure: neuropsychological functioning

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 N40D

genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1). --- Asn40Asp ---

Study outcomes consist of self-report and biological measures of alcohol use; measures of psychiatric symptom severity and neurocognitive functioning; and genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1), which may predict response to naltrexone treatment. --- Asn40Asp ---



HPO Nodes


HPO:
Bipolar affective disorder
Genes 23
COMT SEC24C POLG2 SLC25A4 ARVCF ATP2A2 CDH23 FLI1 MECP2 TWNK USP8 JMJD1C FA2H CHRNA7 TBX1 RRM2B POLG RPS6KA3 UFD1 HIRA GP1BB CLCN4 RREB1
Mania
Genes 23
COMT SEC24C POLG2 SLC25A4 ARVCF ATP2A2 CDH23 FLI1 MECP2 TWNK USP8 JMJD1C FA2H CHRNA7 TBX1 RRM2B POLG RPS6KA3 UFD1 HIRA GP1BB CLCN4 RREB1
Psychosis
Genes 94
NPC1 NHLRC1 MKRN3 SNORD115-1 CACNA1A SLC12A6 CLN8 TMEM106B USP8 PRDM8 EPM2A MAGEL2 PANK2 PSEN1 COX1 COX2 COX3 ACADS PDGFB PDGFRB MAPT ZDHHC9 ATXN7 WFS1 SOBP SQSTM1 SLC20A2 CLN3 PARK7 RPS6KA3 PCDH19 ND1 TBC1D7 ND4 ND5 SLC6A19 ND6 PAH VPS13A NPAP1 TREM2 DCAF17 IPW PRKAR1A PWRN1 PAK3 SPART ALDH18A1 CDH23 HMBS TWNK TRNF ZFYVE26 GRN NPC2 ALAD TRNH NDN NDP UPF3B ABCD1 TRNL1 AIP GNAS PWAR1 HERC2 TRNQ TRNS1 TRNS2 C9ORF72 SLC7A7 TRNW ITM2B ATP13A2 CBS ALDH5A1 MECP2 LMBRD1 KCNT1 SNRPN MED12 SH2B1 SNORD116-1 NAGS PRNP MYORG TTC19 VCP GSS CHMP2B DNMT1 PPOX PDE11A MKRN3-AS1
Schizophrenia
Genes 50
WHRN FLI1 GJA5 GJA8 DNAJC13 CIB2 ARSA PSAP COMT SEC24C CEP78 ARVCF MYO7A ZDHHC9 WFS1 USH1G KRT81 DISC2 KRT83 KRT86 VPS35 UFD1 EIF4G1 LRRK2 PCDH15 GBA CDH23 GIGYF2 TRNE PDZD7 DSG4 UPF3B ADGRV1 HARS SNCA TRNS2 RREB1 USH1C USH2A ATP2A2 CLRN1 JMJD1C MED12 MSTO1 CHRNA7 TBX1 ARSG PRODH HIRA GP1BB