Biomarkers to Measure Treatment Response for Alcohol Dependence

Not Applicable

Completed

• Conditions: Alcohol Dependence
• Interventions: Other: Alcohol administration; Placebo administration

• Registration Number: NCT02315885
• Lead Sponsor: University of Maryland, Baltimore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-05
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-12
• Study Start: 2015-07
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
alcohol middle dose	Alcohol administration; Placebo administration	alcohol dose=0.45g/kg for women and 0.5g/kg for men
placebo alcohol	Alcohol administration; Placebo administration	\<0.05% alcohol
alcohol high dose	Alcohol administration; Placebo administration	alcohol dose=0.90g/kg for women and 1.0g/kg for men

Primary Outcome Measures

Name	Time	Method
Validity of using serotonin transporter mRNA expression 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	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.

Trial Locations

Locations (1)

Clinical Neurobehavioral Center; 🇺🇸 Columbia, Maryland, United States