Biomarkers to Measure Treatment Response for Alcohol Dependence

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT02315885
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Arms: 3
• Duration (Months): 54
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Dependence	Other: Alcohol administration	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Biomarkers to Measure Treatment Response for Alcohol Dependence
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Dec 30, 2019
• Actual Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo alcohol <0.05% alcohol	Other: Alcohol administration; consumption of 3 alcohol doses 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; consumption of 3 alcohol doses 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; consumption of 3 alcohol doses each within 2h on separate days

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Neurobehavioral Center	Columbia	Maryland	United States	21045

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Chamindi Seneviratne, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chamindi Seneviratne, MD, Assistant Professor, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT02315885
• Other Study ID Numbers: HP-00060091
• First Posted: Dec 12, 2014
• Last Update Posted: Jan 24, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chamindi Seneviratne, MD, Assistant Professor, University of Maryland, Baltimore: healthy volunteers; social drinkers; alcohol
• Additional relevant MeSH terms: Alcoholism

Study Results

No Results Posted as of Jan 24, 2022