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Biomarkers to Measure Treatment Response for Alcohol Dependence

Biomarkers to Measure Treatment Response for Alcohol Dependence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02315885
Enrollment
29
Registered
2014-12-12
Start date
2015-07-31
Completion date
2019-12-31
Last updated
2022-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Dependence

Keywords

healthy volunteers, social drinkers, alcohol

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.

Interventions

OTHERAlcohol administration; Placebo administration

consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence

Design outcomes

Primary

MeasureTime frameDescription
Validity of using serotonin transporter mRNA expression levelsWithin 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 dateValidity of using serotonin transporter mRNA expression levels in 5 HTTLPR:LL and rs 25531:AA genotype carriers, as a biomarker of alcohol consumption levels.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026