Biomarkers to Measure Treatment Response for Alcohol Dependence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Validity of using serotonin transporter mRNA expression levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
alcohol middle dose
alcohol dose=0.45g/kg for women and 0.5g/kg for men
Intervention: Alcohol administration; Placebo administration (Other)
alcohol high dose
alcohol dose=0.90g/kg for women and 1.0g/kg for men
Intervention: Alcohol administration; Placebo administration (Other)
placebo alcohol
<0.05% alcohol
Intervention: Alcohol administration; Placebo administration (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Chamindi Seneviratne, MD
Assistant Professor
University of Maryland, Baltimore