Alcohol DependenceNCT02315885
Biomarkers to Measure Treatment Response for Alcohol Dependence
A study of Alcohol Dependence, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Neurobehavioral Center
Columbia, Maryland, 21045
About this study
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.
- Conditions
- Alcohol Dependence
- Being tested
- Alcohol administration; Placebo administration
- Keywords
- healthy volunteers, social drinkers, alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol administration; Placebo administrationOther
consumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days
| Study group | Role | What they receive |
|---|---|---|
| placebo alcohol | Placebo comparator | <0.05% alcohol Receives: Other: Alcohol administration; Placebo administration |
| alcohol middle dose | Active comparator | alcohol dose=0.45g/kg for women and 0.5g/kg for men Receives: Other: Alcohol administration; Placebo administration |
| alcohol high dose | Active comparator | alcohol dose=0.90g/kg for women and 1.0g/kg for men Receives: Other: Alcohol administration; Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJul 2015
- Primary completion30 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chamindi Seneviratne, MD, University of Maryland, Baltimore
- Investigators
- Chamindi Seneviratne, Principal investigator, csenevi@som.umaryland.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315885
- Sponsor's protocol ID
- HP-00060091
- Status last verified
- Aug 2022
- First submitted
- 5 Dec 2014
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers to Measure Treatment Response for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT02315885
- Acronym / sponsor ID
- HP-00060091
- Conditions
- Alcohol Dependence
- Keywords
- healthy volunteers, social drinkers, alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo alcohol | Placebo comparator | Other: Alcohol administration; Placebo administration<0.05% alcohol |
| alcohol middle dose | Active comparator | Other: Alcohol administration; Placebo administrationalcohol dose=0.45g/kg for women and 0.5g/kg for men |
| alcohol high dose | Active comparator | Other: Alcohol administration; Placebo administrationalcohol dose=0.90g/kg for women and 1.0g/kg for men |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol administration; Placebo administrationconsumption of 3 alcohol doses (2 regular and one placebo) each within 2h on separate days | Other | alcohol high dose, alcohol middle dose, placebo alcohol |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chamindi Seneviratne principal investigator
csenevi@som.umaryland.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Alcohol Dependence, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.