Biomarkers to Measure Treatment Response for Alcohol Dependence

August 29, 2022 updated by: Chamindi Seneviratne, MD, University of Maryland, Baltimore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Columbia, Maryland, United States, 21045
        • Clinical Neurobehavioral Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo alcohol
<0.05% alcohol
Other: Alcohol administration; Placebo administration
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days
Active Comparator: alcohol middle dose
alcohol dose=0.45g/kg for women and 0.5g/kg for men
Other: Alcohol administration; Placebo administration
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days
Active Comparator: alcohol high dose
alcohol dose=0.90g/kg for women and 1.0g/kg for men
Other: Alcohol administration; Placebo administration
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validity of using serotonin transporter mRNA expression levels
Time Frame: 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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Chamindi Seneviratne, csenevi@som.umaryland.edu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

December 5, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00060091

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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