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NCT01585168 · ClinicalTrials.gov registry record · Phase 2

Functional Neuroimaging of Alcoholism Vulnerability (PIT)

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
71
Enrollment target

NCT01585168: Completed Phase 2 study, sponsored by Yale University.

NCT01585168 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01585168, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target

Study Summary

This project compares Family History Positive (FHP) for alcoholism subjects to matched Family History Negative (FHN) subjects derived from the project Principal Investigator's National Institute on Alcohol Abuse and Alcoholism-funded longitudinal study of drinking behavior in a 2000 college freshman population (known as the Brain and Alcohol Research in College Students study (BARCS)). The age of these subjects is a valuable one at which to capture the transition from harmful use to abuse/dependence. This project explores the effects of memantine in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant tasks. More specifically, this project studies functional MRI tasks related to different aspects of reward and/or impulsivity-related behavior in different contexts, compares the underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic system to examine NMDA/DA interactions. The combined measures provide the opportunity to advance our understanding of specific aspects of brain function related to familial alcoholism vulnerability in an already well-characterized population as some members evolve into alcohol abuse. In addition to conventional within-task analyses, functional network connectivity and allied approaches will be used to examine brain networks across tasks. The investigators will study adult male and female subjects in equal numbers who are either offspring of an alcoholic parent or are FHN matched controls. The investigators will recruit and assess a total of 84 (42 FHP and 42 matched FHN) subjects between the ages of 18-21 years on initial BARCS contact. The investigators will use 4 cognitive tasks during the functional MRI (fMRI) which include: 1) a Monetary Incentive Delay Task that distinguishes networks engaged in motivational (anticipation) and consummatory (outcome) components of reward processing; 2) a Go/No-Go Task that measures the ability to inhibit response to a pre-potent stimulus

Primary Outcome

All participants completed the fMRI Monetary Incentive Delay task on each study day. During the task, participants needed to select the correct response during "win" and "lose" conditions by pressing a button on a button box in the MRI. Participant's BOLD activation response (A measurement of oxygen level that is released to neurons since areas of the brain that are thought to be more "active" or involved in certain tasks require more oxygen to perform the tasks.) was measured while they perform

Interventions

  • DRUG Placebo
  • DRUG Memantine

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2011-12
Est. Completion 2016-05
Phase Phase 2
Yale University

1,492 total trials

What the finished NCT01585168 record still lists

NCT01585168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01585168 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01585168 about?

NCT01585168 is a clinical study titled "Functional Neuroimaging of Alcoholism Vulnerability (PIT)". This project compares Family History Positive (FHP) for alcoholism subjects to matched Family History Negative (FHN) subjects derived from the project Principal Investigator's National Institute on Alcohol Abuse and Alcoholism-funded longitudinal study of drinking behavior in a 2000 college freshman...

What is the current status of trial NCT01585168?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2011-12. Estimated completion is 2016-05.

What interventions are being tested in trial NCT01585168?

The interventions under investigation include: Placebo (DRUG), Memantine (DRUG).

Who is sponsoring clinical trial NCT01585168?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01585168's enrollment target sits among peer trials

71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01585168, the US trial registry maintained by the National Library of Medicine. NCT01585168 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.