Biomarkers to Measure Treatment Response for Alcohol Dependence
1 other identifier
interventional
29
1 country
1
Brief Summary
The purpose of the research study of the K23 award is to develop a blood test that can check how much alcohol a person has consumed in the past few days. We will enroll heavy social drinkers who do not have alcohol-related problems but used to drinking 5 or more beers on a single occasion. Both men and women between ages 21 and 65 years can join the study. All participants must be of European decent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2014
CompletedFirst Posted
Study publicly available on registry
December 12, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedSeptember 1, 2022
August 1, 2022
4.5 years
December 5, 2014
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validity of using serotonin transporter mRNA expression levels
Validity of using serotonin transporter mRNA expression levels in 5 HTTLPR:LL and rs 25531:AA genotype carriers, as a biomarker of alcohol consumption levels.
Within 24 hours of blood sample collection and in archived blood samples from the same participant stores at -80 degrees celsius for a duration of 6 months or more from the collection date
Study Arms (3)
placebo alcohol
PLACEBO COMPARATOR\<0.05% alcohol
alcohol middle dose
ACTIVE COMPARATORalcohol dose=0.45g/kg for women and 0.5g/kg for men
alcohol high dose
ACTIVE COMPARATORalcohol dose=0.90g/kg for women and 1.0g/kg for men
Interventions
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days
Eligibility Criteria
You may qualify if:
- Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days
You may not qualify if:
- DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Neurobehavioral Center
Columbia, Maryland, 21045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chamindi Seneviratne
csenevi@som.umaryland.edu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 5, 2014
First Posted
December 12, 2014
Study Start
July 1, 2015
Primary Completion
December 30, 2019
Study Completion
December 31, 2019
Last Updated
September 1, 2022
Record last verified: 2022-08