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NCT03294460 · ClinicalTrials.gov registry record · Phase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
A Phase 1 study of Alcohol Drinking, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT03294460: Recruiting Phase 1 study of Alcohol Drinking, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
NCT03294460 is a Phase 1 study of Alcohol Drinking that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 128 participants, below the 629-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03294460, a Phase 1 study of Alcohol Drinking, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: People with the brain disease AUD (alcohol use disorder) have a serious problem with drinking. Researchers want to study 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. Objectives: To see if people with variations of a nicotine receptor gene take alcohol differently and have different brain responses to alcohol cues. Eligibility: Healthy adults ages 21 - 60. This study includes smokers and non-smokers. Design: Participation will be based on evaluation under the NIAAA natural history protocol (14-AA-0181) or a screening visit under this protocol. Participants will have two 9-hour visits. They must have no alcohol or non-prescription drugs before all visits and no food or drink before the first visit. At every visit, participants will: * Get a light meal * Have breath and urine tests * Get taxi rides there and back At visits 1, participants will: * Have a thin plastic tube inserted in an arm and connected to a pump for alcohol infusion. * Have sensors on their chest to monitor heart rate. * Sit in a chair for 2.5 hours and get alcohol by pushing a button. Their breath alcohol level will be monitored. * Answer questions about mood and effects of alcohol * Give blood samples * Relax at the clinic while their breath alcohol level drops At visit 2, participants will: * Answer questions and do computer tests * Have an alcoholic drink and a snack * Have a magnetic resonance imaging (MRI) scan. They will lie in a machine that takes pictures of the brain. They will do computer tasks. * Have another drink and snack * Relax until their alcohol level drops Participants will have a follow-up call after each visit.
Primary Outcome
The following measures will be examined as a function of smoking status (smokers and non-smokers) and CHRNA5 genotype. The influence of sex, age, and recent drinking history will be examined as covariates. Primary outcome measures include: (1a) BrAC exposure (peak BrAC, number of infusions, time to binge-level BrAC) during the free-access IV-ASA; (1b) BOLD response during the AFID task in neural regions associated with alcohol reward processing, including ventral striatum, amygdala, and insula.
Conditions Studied
Interventions
- DRUG Alcohol (Oral)
- DRUG Alcohol (IV)
- DRUG Alcohol (Ethanol)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What NCT03294460 shows while recruiting
NCT03294460 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 629-participant average among 85 other Alcohol Drinking trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Alcohol Drinking appearing as the primary indexed condition, and to 3 interventions - of which Alcohol (Oral) is the first listed.
NCT03294460 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03294460 about?
NCT03294460 is a clinical study titled "Nicotinic Receptor Genetic Variation and Alcohol Reward". Background: People with the brain disease AUD (alcohol use disorder) have a serious problem with drinking. Researchers want to study 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. Objectives: To ...
What is the current status of trial NCT03294460?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2019-06-10. Estimated completion is 2026-12-31.
What conditions does trial NCT03294460 study?
This clinical trial studies the following conditions: Alcohol Drinking.
What interventions are being tested in trial NCT03294460?
The interventions under investigation include: Alcohol (Oral) (DRUG), Alcohol (IV) (DRUG), Alcohol (Ethanol) (DRUG).
Who is sponsoring clinical trial NCT03294460?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03294460 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Drinking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03294460's enrollment target sits among peer trials
128 51st of 85 higher than 35 of 85 other Alcohol Drinking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Drinking trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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