Biomarkers to Measure Treatment Response for Alcohol Dependence

NCT ID: NCT02315885

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo alcohol

\<0.05% alcohol

Group Type PLACEBO_COMPARATOR

Alcohol administration; Placebo administration

Intervention Type OTHER

consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

alcohol middle dose

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

Group Type ACTIVE_COMPARATOR

Alcohol administration; Placebo administration

Intervention Type OTHER

consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

alcohol high dose

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

Group Type ACTIVE_COMPARATOR

Alcohol administration; Placebo administration

Intervention Type OTHER

consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

Interventions

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Alcohol administration; Placebo administration

consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Chamindi Seneviratne, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chamindi Seneviratne

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Clinical Neurobehavioral Center

Columbia, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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HP-00060091

Identifier Type: -

Identifier Source: org_study_id

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