Biomarkers to Measure Treatment Response for Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

Biomarkers to Measure Treatment Response for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315885
• Other study ID #: HP-00060091
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 31, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Other:
• Alcohol administration; Placebo administration
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

Locations

Country	Name	City	State
United States	Clinical Neurobehavioral Center	Columbia	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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