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Biomarkers to Measure Treatment Response for Alcohol Dependence

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alcohol administration; Placebo administration
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Dependence focused on measuring healthy volunteers, social drinkers, alcohol

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Neurobehavioral Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo alcohol

alcohol middle dose

alcohol high dose

Arm Description

<0.05% alcohol

alcohol dose=0.45g/kg for women and 0.5g/kg for men

alcohol dose=0.90g/kg for women and 1.0g/kg for men

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2014
Last Updated
August 29, 2022
Sponsor
University of Maryland, Baltimore
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1. Study Identification

Unique Protocol Identification Number
NCT02315885
Brief Title
Biomarkers to Measure Treatment Response for Alcohol Dependence
Official Title
Biomarkers to Measure Treatment Response for Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
healthy volunteers, social drinkers, alcohol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo alcohol
Arm Type
Placebo Comparator
Arm Description
<0.05% alcohol
Arm Title
alcohol middle dose
Arm Type
Active Comparator
Arm Description
alcohol dose=0.45g/kg for women and 0.5g/kg for men
Arm Title
alcohol high dose
Arm Type
Active Comparator
Arm Description
alcohol dose=0.90g/kg for women and 1.0g/kg for men
Intervention Type
Other
Intervention Name(s)
Alcohol administration; Placebo administration
Intervention Description
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days
Primary Outcome Measure Information:
Title
Validity of using serotonin transporter mRNA expression levels
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chamindi Seneviratne
Organizational Affiliation
csenevi@som.umaryland.edu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Neurobehavioral Center
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Biomarkers to Measure Treatment Response for Alcohol Dependence

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