Biomarkers to Measure Treatment Response for Alcohol Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02315885
Recruitment Status : Recruiting
First Posted : December 12, 2014
Last Update Posted : August 18, 2017
Information provided by (Responsible Party):
Chamindi Seneviratne, University of Maryland

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.

Condition or disease Intervention/treatment
Alcohol Dependence Other: Alcohol administration

Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Biomarkers to Measure Treatment Response for Alcohol Dependence
Study Start Date : July 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. [ 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy volunteers who drink heavily.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02315885

Contact: Olga Kolesnik 667-214-2003

United States, Maryland
CNC Recruiting
Columbia, Maryland, United States
Contact: Olga Kolesnik         
Sponsors and Collaborators
University of Maryland
Principal Investigator: Chamindi Seneviratne

Responsible Party: Chamindi Seneviratne, Assistant Professor, University of Maryland Identifier: NCT02315885     History of Changes
Other Study ID Numbers: HP-00060091
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chamindi Seneviratne, University of Maryland:
healthy volunteers
social drinkers

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs