Trial · NCT01585168
Functional Neuroimaging of Alcoholism Vulnerability (PIT)
NCT01585168, Phase 2, Completed, Yale University; results first posted 2018-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Functional Neuroimaging of Alcoholism Vulnerability (PIT). Trials, record NCT01585168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01585168
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Functional Neuroimaging of Alcoholism Vulnerability (PIT)
- NCT number
- NCT01585168
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Healthy
- Interventions
- Memantine, Placebo
- First posted
- 2012-04-25
- Last updated
- 2021-03-16
- Results first posted
- 2018-05-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During "Win" Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | 4 hours post intervention on each study day, separated by 1 week to 1 month | 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 performed the task in MRI scanner. |
| Primary | Change in Blood Oxygenation Level Dependent (BOLD) Activation in Anterior Cingulate Cortex During "Loss" Condition of Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | 4 hours post intervention on each study day, separated by 1 week to 1 month | 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 performed the task in MRI scanner. |
| Secondary | Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication | 3 hours post intervention on each study day, separated by 1 week to 1 month | All participants completed the BART task approximately 3 hours post drug administration on both study visits. Study days were approximately 1 week to 1 month a part. BART is a computer decision-making task that measures risk taking. Participants are presented with a series of "balloons." The object is to earn as much money as possible by pumping the balloon without popping it. The point of explosion varies from trial to trial and costs participants the money they have earned in that trial. |
| Secondary | Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication | 3 hours post intervention on each study day, separated by 1 week to 1 month | All participants completed the EDT task approximately 3 hours post drug administration on both study visits. Study days were approximately 1 week to 1 month a part. EDT is a delay-discounting task that exposes participants to choice consequences during test administration. The EDT involves multiple blocks of choices, one for each delay. Choices are made between a standard amount that is delivered immediately and is certain and a probable amount that is delayed and uncertain. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | 4 hours post intervention on each study day, separated by 1 week to 1 month | The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment. | voxel wise BOLD signal | MEAN |
| SECONDARY | Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication | 3 hours post intervention on each study day, separated by 1 week to 1 month | Participants with a family history of alcoholism (family history positive) and without a history of alcoholism (family history negative) who completed BART task. | total pumps | MEAN |
| SECONDARY | Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication | 3 hours post intervention on each study day, separated by 1 week to 1 month | responses | MEAN | |
| PRIMARY | Change in Blood Oxygenation Level Dependent (BOLD) Activation in Anterior Cingulate Cortex During Loss Condition of Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | 4 hours post intervention on each study day, separated by 1 week to 1 month | The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment. | voxel wise BOLD signal | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | FHN - Memantine | -0.6994 | Standard Deviation 3.8049 | voxel wise BOLD signal | |
| Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | FHN - Placebo | 1.7115 | Standard Deviation 3.9355 | voxel wise BOLD signal | |
| Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | FHP - Memantine | 0.3683 | Standard Deviation 3.9475 | voxel wise BOLD signal | |
| Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During Win Monetary Incentive Delay (MID) Task Between Placebo and Study Medication | FHP - Placebo | 4.0298 | Standard Deviation 5.6935 | voxel wise BOLD signal | |
| Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication | FHN - Memantine | -0.12839 | Standard Deviation 1.001 | total pumps | |
| Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication | FHN - Placebo | -0.04331 | Standard Deviation 1.033 | total pumps | |
| Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication | FHP - Memantine | 0.2727 | Standard Deviation 0.910 | total pumps | |
| Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication | FHP - Placebo | -0.0789 | Standard Deviation 1.022 | total pumps | |
| Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication | FHN - Memantine | # of times delayed pressed in Delay Condition | 13.58831 | Standard Deviation 6.838454 | responses |
| Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication | FHN - Placebo | # of times delayed pressed in Delay Condition | 14.13 | Standard Deviation 7.414 | responses |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Family History Negative (FHN): Memantine, Then Placebo | 18 | |
| Overall Study | STARTED | Family History Negative (FHN): Placebo, Then Memantine | 18 | |
| Overall Study | STARTED | Family History Positive (FHP): Memantine, Then Placebo | 16 | |
| Overall Study | STARTED | Family History Positive (FHP): Placebo, Then Memantine | 19 | |
| Overall Study | COMPLETED | Family History Negative (FHN): Memantine, Then Placebo | 15 | |
| Overall Study | COMPLETED | Family History Negative (FHN): Placebo, Then Memantine | 17 | |
| Overall Study | COMPLETED | Family History Positive (FHP): Memantine, Then Placebo | 15 | |
| Overall Study | COMPLETED | Family History Positive (FHP): Placebo, Then Memantine | 18 | |
| Overall Study | NOT COMPLETED | Family History Negative (FHN): Memantine, Then Placebo | 3 | |
| Overall Study | NOT COMPLETED | Family History Negative (FHN): Placebo, Then Memantine | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | General disorders | Family History Positive (FHP) | 14 | 35 | 14 |
| other | Dizziness | General disorders | Family History Negative (FHN) | 12 | 36 | 12 |
| other | Lightheaded | General disorders | Family History Positive (FHP) | 19 | 35 | 19 |
| other | Lightheaded | General disorders | Family History Negative (FHN) | 17 | 36 | 17 |
| other | Drunk or Tipsy | General disorders | Family History Positive (FHP) | 5 | 35 | 5 |
| other | Drunk or Tipsy | General disorders | Family History Negative (FHN) | 2 | 36 | 2 |
| other | Nausea | General disorders | Family History Positive (FHP) | 2 | 35 | 2 |
| other | Nausea | General disorders | Family History Negative (FHN) | 2 | 36 | 2 |
| other | Vomit | General disorders | Family History Positive (FHP) | 0 | 35 | 0 |
| other | Vomit | General disorders | Family History Negative (FHN) | 1 | 36 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Family History Positive (FHP) | 0 | 35 |
| Total, all-cause mortality | Family History Negative (FHN) | 0 | 36 |
| Total, other adverse events | Family History Positive (FHP) | 24 | 35 |
| Total, other adverse events | Family History Negative (FHN) | 26 | 36 |
| Total, serious adverse events | Family History Positive (FHP) | 0 | 35 |
| Total, serious adverse events | Family History Negative (FHN) | 0 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Family History Positive (FHP) vs Family History Negative (FHN): deaths from any cause | Trial comparisons |
| Family History Positive (FHP) vs Family History Negative (FHN): serious adverse events | Trial comparisons |
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Monetary Incentive Delay | Primary outcome | ConductCognition |
| Balloon Risk | Secondary outcome | ConductCognition |
| Delay Discounting | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01585168
GET https://conductscience.org/api/trials/v1/NCT01585168/results?page=2