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Alcohol Response and Genetics for Alcohol Consumption

Phase 1
Recruiting
Led By Vijay A Ramchandani, Ph.D.
Research Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female participants between 21-60 years of age
Non-smokers with no history of smoking in the past year and less than 20 uses of nicotinic products lifetime
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Awards & highlights

Study Summary

This trial is studying how different people react to alcohol, and how genes affect this. They will focus on a nicotine receptor gene that may increase a person's AUD risk.

Who is the study for?
Adults aged 21-60, both smokers (with at least a year of daily smoking and certain cotinine levels) and non-smokers (with no recent smoking history), can join this study. Women must use effective birth control if they're sexually active. People with alcohol or substance disorders, seeking treatment for such issues, or with significant withdrawal symptoms are excluded.Check my eligibility
What is being tested?
The trial is testing how genetic variations in a nicotine receptor gene affect the way people consume alcohol and their brain's response to it. Participants will undergo two sessions involving alcohol consumption via different methods and monitoring through breath tests, blood samples, questionnaires, and MRI scans.See study design
What are the potential side effects?
Potential side effects from participating in this trial may include the common effects of alcohol consumption such as dizziness, nausea, mood changes, coordination problems, and altered judgment. The MRI scan could cause discomfort for those who have claustrophobia or fear enclosed spaces.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 60 years old.
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I have not smoked or used nicotine products more than 20 times in my life.
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I am using effective birth control or do not need it due to my or my partner's sterilization.
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I am using effective birth control or do not need it due to my or my partner's sterilization.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To examine the effect of CHRNA5 (rs16969968) genetic variation on IV alcohol self-administration, as measured by BrAC exposure (peak BrAC, number of infusions, time to binge-level) in non-smoking, non-dependent drinkers.
To examine the effect of CHRNA5 (rs16969968) genetic variation on neural correlates of incentive salience for alcohol, as measured by BOLD response during the Alcohol-Food Incentive Delay (AFID) task using fMRI.
Secondary outcome measures
To examine the effect of CHRNA5 (rs16969968) genetic variation on resting-state functional connectivity (rsFC) among brain regions associated with the salience network, including dorsal anterior cingulate cortex, ventral striatum and extended am...
To examine the effect of CHRNA5 (rs16969968) genetic variation on the rate of IV alcohol self-administration, as measured by the preferred rate during the second IV-ASA session in non-smoking, non-dependent drinkers.
To examine the relationship between fMRI measures (BOLD response during AFID and rsFC measures) and IV alcohol self-administration, and any differences in the degree of association among these measures by CHRNA5 genotype.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment3 Interventions
Alcohol self-administration (IV ethanol for sessions 1 and oral for session 2)

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)Lead Sponsor
802 Previous Clinical Trials
1,365,317 Total Patients Enrolled
Vijay A Ramchandani, Ph.D.Principal InvestigatorNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
7 Previous Clinical Trials
1,840 Total Patients Enrolled

Media Library

Alcohol Reward (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03294460 — Phase 1
Alcohol Consumption Research Study Groups: 1
Alcohol Consumption Clinical Trial 2023: Alcohol Reward Highlights & Side Effects. Trial Name: NCT03294460 — Phase 1
Alcohol Reward (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03294460 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risk factors are associated with the consumption of alcoholic beverages?

"The safety of Oral Alcohol was assessed to be a 1 due to the lack of clinical evidence in this Phase 1 trial."

Answered by AI

Does this investigation currently need more participants?

"Affirmative. Clinicaltrials.gov data indicates that this particular clinical trial has been actively recruiting since June 10th 2019 and is currently open for 128 patients from one site. The listing was last updated on November 18th 2022."

Answered by AI

Is the age of candidacy for this trial restricted to individuals over 25?

"The current parameters of this medical trial stipulate that participants must range in age from 21 to 60. For those younger than 18, there are 25 studies available; and for individuals older than 65, 176 options exist."

Answered by AI

What medical conditions typically require the administration of Alcohol (Oral)?

"Obstructive hypertrophic cardiomyopathy can be managed with oral Alcohol. This substance is also an efficacious treatment for communicable diseases, ethylene glycol poisoning, and skin disinfection therapies."

Answered by AI

Is participation in this experiment feasible for me?

"This trial is recruiting 128 individuals, aged 21 to 60, who have a history of consuming alcohol. Additionally, the participants must conform to other requirements: Male and female applicants between ages 21-60 (verification documents required), male or female smokers with at least 1 year of daily use of nicotine products and cotinine levels above 2 (Smoking history questionnaire, Additional medical history, PreDosage Nicotine test mandatory). Women need reliable birth control methods during their participation in this study (medical history verification needed) while non-smokers are accepted if they haven't used nicotine products for more than one year (smoking history questionnaire and additional"

Answered by AI

What is the upper limit for enrolment in this clinical experiment?

"Indeed, the information on clinicaltrials.gov suggests that this medical research is open to further recruitment. Initially posted in June of 2019 and recently updated on November 18th 2022, the study requires 128 participants at a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Nicotinic Receptor Genetic Variation and Alcohol Reward
2019. "Nicotinic Receptor Genetic Variation and Alcohol Reward". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03294460.
~16 spots leftby Dec 2024
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