Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms
Summary
Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief psychological counseling. Randomization will be stratified by gender and level of alcohol consumption prior to enrollment in the study
Description
Target enrollment of subjects with AUD who regularly engage in risk alcohol consumption (i.e. >6/day or more heavy alcohol consumption in the 4 weeks preceding the screening visit), and have selected genotypes (LL/TT genotype and/or 1, 2 or 3 of the SNPs on the genes for the 5-HT3 receptor subunits: rs1150226-AG or rs1176713-GG in the gene that encodes the 5-HT3A receptor subunit, and rs17614942-AC in the gene that encodes the 5-HT3B receptor subunit), and who are eligible to participate in the study based on meeting the remaining study inclusion/exclusion criteria. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo BID for 24 weeks.
The trial will have a 16-week grace period to enable medication effects to be optimal for comparison with placebo. The grace period starts immediately after beginning of study drug treatment, in which consumption of alcohol is not counted as a failure. All primary and secondary efficacy endpoints will be assessed during the last 8 weeks of treatment (i.e. weeks 17-24). The primary measure of efficacy, incidence risk alcohol consumption, will be assessed over the last 8 weeks of treatment. To enhance study feasibility, subjects will be evaluated every week during the first 8 weeks of treatment and every other week for the remaining 16 weeks of the treatment period.
Study Design
Conditions
Alcohol Use Disorder
Intervention
AD04 (ondansetron), Matching placebo, Companion Diagnostic for Genetic Testing, Brief Psychological Counseling
Status
Not yet recruiting
Source
Adial Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04101227
- ClinicalTrials.gov processed this data on September 26, 2019
Published on BioPortfolio: 2019-09-27T06:30:39-0400
Clinical Trials
Matching Genotypes and Serotonergic Medications for Alcoholism
The purpose the study is to investigate whether people with certain genetic traits who are receiving treatment with ondansetron or sertraline will see a significant reduction in alcohol co...
Efficacy of Ondansetron in LARS Treatment
Patients will be randomized (1:1 ratio) to receive either 4 weeks of Ondansetron followed by 4 weeks of placebo (O-P sequence) or 4 weeks of placebo followed by 4 weeks of Ondansetron (P-O...
Does IV Ondansetron Prevent Pruritus After Intrathecal Morphine in Pediatric Patients?
This is a prospective randomized, double-blind, placebo-controlled study to compare the incidence and intensity of ITM-induced pruritus and nausea/vomiting using pre-emptive IV ondansetron...
Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
This is a double-blind, two period, two treatment crossover trial of ondansetron verses placebo studying the effects of ondansetron in the small and large bowel, specifically its effects o...
Ondansetron for the Treatment of IBS With Diarrhoea (IBS-D)
Irritable bowel syndrome is a common condition affecting 1 in 10 of the population. About a third of these suffer from diarrhoea, which severely impairs their quality of life. Previous st...
PubMed Articles
To investigate the validity, accuracy, and clinical outcomes of Karyomapping in preimplantation genetic testing (PGT) for β-thalassemia combined with human leukocyte antigen (HLA) matching.
Direct-to-consumer genetic testing.
Direct-to-consumer (DTC) genetic testing is a controversial issue although Korean Government is considering to expand DTC genetic testing. Preventing the exaggeration and abusing of DTC genetic testin...
Background An increasing number of diagnostic evaluations incorporate genetic testing to facilitate accurate and timely diagnoses. The increasing number and complexity of genetic tests continue to pos...
Diagnostic Genetic Testing for Monogenic Diabetes and Congenital Hyperinsulinemia.
Monogenic diabetes and hyperinsulinism are genetically heterogeneous disorders. The determination of the genetic etiology defines the diagnostic subtype, predicts prognosis, and importantly can guide ...
Malignant Hyperthermia - Diagnosis in Practice.
Testing for malignant hyperthermia (MH) susceptibility is usually performed either in relatives of MH susceptible persons or in patients with an MH suspicious clinical event. There are two diagnostic ...
Medical and Biotech [MESH] Definitions
Direct-to-consumer Screening And Testing
Laboratory testing and diagnostic imaging services offered to consumers outside of the patient-physician relationship.
Laboratory Proficiency Testing
Assessments aimed at determining agreement in diagnostic test results among laboratories. Identical survey samples are distributed to participating laboratories, with results stratified according to testing methodologies.
Point-of-care Testing
Allows patient diagnoses in the physician’s office, in other ambulatory setting or at bedside. The results of care are timely, and allow rapid treatment to the patient. (from NIH Fact Sheet Point-of-Care Diagnostic Testing, 2010.)
Diagnostic Test Approval
The process of gaining approval by a government regulatory agency for DIAGNOSTIC REAGENTS AND TEST KITS. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance.
Animal Testing Alternatives
Procedures, such as TISSUE CULTURE TECHNIQUES; mathematical models; etc., when used or advocated for use in place of the use of animals in research or diagnostic laboratories.
More From BioPortfolio on "Study to Evaluate AD04 in Adults With Alcohol Use Disorder (AUD) and Selected Serotonin Transporter Polymorphisms"
Quick Links
Advanced Search |
Login |
Subscribe |
RSS 
BioPortfolio Twitter Channels (200+ Accounts)
LinkedIn