Trial Outcomes & Findings for Functional Neuroimaging of Alcoholism Vulnerability (PIT) (NCT NCT01585168)
NCT ID: NCT01585168
Last Updated: 2021-03-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
4 hours post intervention on each study day, separated by 1 week to 1 month
Results posted on
2021-03-16
Participant Flow
82 participants were screened for eligibility and then were consented at the Olin Research Center. However, after consent and prior to group randomization, 11 participants were excluded from the study due to follow-up eligibility paperwork (i.e. psychiatric interview, family history review, etc.) for a total of 71 randomized.
Participant milestones
| Measure |
Family History Negative (FHN): Memantine, Then Placebo
Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
Family History Negative (FHN): Placebo, Then Memantine
Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
Family History Positive (FHP): Memantine, Then Placebo
Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
Family History Positive (FHP): Placebo, Then Memantine
Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
16
|
19
|
|
Overall Study
COMPLETED
|
15
|
17
|
15
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Family History Negative (FHN): Memantine, Then Placebo
Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
Family History Negative (FHN): Placebo, Then Memantine
Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
Family History Positive (FHP): Memantine, Then Placebo
Participants received 2-20mg tablets of Memantine on the morning of the first study visit, then received 2 matching placebo tablets on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
Family History Positive (FHP): Placebo, Then Memantine
Participants received 2 matching placebo tablets on the morning of the first study visit, then received 2-20mg tablets of Memantine on the morning of the second study visit. Visits were approximately 1 week to 1 month a part on average.
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
1
|
1
|
Baseline Characteristics
The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
Baseline characteristics by cohort
| Measure |
Family History Positive (FHP)
n=35 Participants
People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
Family History Negative (FHN)
n=36 Participants
People who have no affected first- or second-degree relatives.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=35 Participants
|
36 Participants
n=36 Participants
|
71 Participants
n=71 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=35 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=71 Participants
|
|
Age, Continuous
|
24.70 years
n=33 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
22.09 years
n=32 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
23.42 years
n=65 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
|
Sex: Female, Male
Female
|
28 Participants
n=33 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
20 Participants
n=32 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
48 Participants
n=65 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
|
Sex: Female, Male
Male
|
5 Participants
n=33 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
12 Participants
n=32 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
17 Participants
n=65 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
|
Region of Enrollment
United States
|
33 participants
n=33 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
32 participants
n=32 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
65 participants
n=65 Participants • The number of participants analyzed is different from the overall baseline participants because a total of 6 participants (2 FHP, 4 FHN) did not complete both of the interventions (memantine, placebo) due to lost to follow-up.
|
PRIMARY outcome
Timeframe: 4 hours post intervention on each study day, separated by 1 week to 1 monthPopulation: The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment.
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.
Outcome measures
| Measure |
FHN - Memantine
n=27 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHN - Placebo
n=27 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHP - Memantine
n=12 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
FHP - Placebo
n=12 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
|---|---|---|---|---|
|
Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During "Win" Monetary Incentive Delay (MID) Task Between Placebo and Study Medication
|
-0.6994 voxel wise BOLD signal
Standard Deviation 3.8049
|
1.7115 voxel wise BOLD signal
Standard Deviation 3.9355
|
0.3683 voxel wise BOLD signal
Standard Deviation 3.9475
|
4.0298 voxel wise BOLD signal
Standard Deviation 5.6935
|
PRIMARY outcome
Timeframe: 4 hours post intervention on each study day, separated by 1 week to 1 monthPopulation: The number of subjects analyzed differs from the overall number of subjects because analyses for this measure occurred about 48 months into recruitment.
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.
Outcome measures
| Measure |
FHN - Memantine
n=27 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHN - Placebo
n=27 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHP - Memantine
n=12 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
FHP - Placebo
n=12 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
|---|---|---|---|---|
|
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
|
-0.5980 voxel wise BOLD signal
Standard Deviation 2.9465
|
1.2368 voxel wise BOLD signal
Standard Deviation 2.8177
|
.7498 voxel wise BOLD signal
Standard Deviation 3.1314
|
3.4762 voxel wise BOLD signal
Standard Deviation 2.3169
|
SECONDARY outcome
Timeframe: 3 hours post intervention on each study day, separated by 1 week to 1 monthPopulation: Participants with a family history of alcoholism (family history positive) and without a history of alcoholism (family history negative) who completed BART task.
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.
Outcome measures
| Measure |
FHN - Memantine
n=18 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHN - Placebo
n=19 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHP - Memantine
n=19 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
FHP - Placebo
n=26 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
|---|---|---|---|---|
|
Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication
|
-0.12839 total pumps
Standard Deviation 1.001
|
-0.04331 total pumps
Standard Deviation 1.033
|
0.2727 total pumps
Standard Deviation 0.910
|
-0.0789 total pumps
Standard Deviation 1.022
|
SECONDARY outcome
Timeframe: 3 hours post intervention on each study day, separated by 1 week to 1 monthAll 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.
Outcome measures
| Measure |
FHN - Memantine
n=32 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHN - Placebo
n=32 Participants
Family History Negative (FHN): People who have no affected first- or second-degree relatives.
|
FHP - Memantine
n=33 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
FHP - Placebo
n=33 Participants
Family History Positive (FHP): People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
|---|---|---|---|---|
|
Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication
# of times "delayed" pressed in Delay Condition
|
13.58831 responses
Standard Deviation 6.838454
|
14.13 responses
Standard Deviation 7.414
|
15.41029 responses
Standard Deviation 8.256729
|
13.64 responses
Standard Deviation 7.504
|
|
Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication
# of times "immediate" pressed in Delay Condition
|
10.85871 responses
Standard Deviation 6.972910
|
11.84 responses
Standard Deviation 7.133
|
10.34057 responses
Standard Deviation 5.995089
|
10.22 responses
Standard Deviation 5.873
|
|
Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication
# of times "delayed" pressed in Immediate Cond.
|
11.44094 responses
Standard Deviation 3.890267
|
11.94 responses
Standard Deviation 4.096
|
11.77072 responses
Standard Deviation 4.882568
|
11.50 responses
Standard Deviation 4.159
|
|
Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication
# of times "immediate" pressed in Immediate Cond.
|
18.57818 responses
Standard Deviation 12.316437
|
17.74 responses
Standard Deviation 10.847
|
14.82459 responses
Standard Deviation 9.884165
|
14.39 responses
Standard Deviation 10.431
|
Adverse Events
Family History Positive (FHP)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Family History Negative (FHN)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Family History Positive (FHP)
n=35 participants at risk
People who have a biological father with alcoholism and at least one other first- or second-degree relative with alcoholism.
|
Family History Negative (FHN)
n=36 participants at risk
People who have no affected first- or second-degree relatives.
|
|---|---|---|
|
General disorders
Dizziness
|
40.0%
14/35 • Number of events 14 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
33.3%
12/36 • Number of events 12 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
|
General disorders
Lightheaded
|
54.3%
19/35 • Number of events 19 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
47.2%
17/36 • Number of events 17 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
|
General disorders
"Drunk" or "Tipsy"
|
14.3%
5/35 • Number of events 5 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
5.6%
2/36 • Number of events 2 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
|
General disorders
Nausea
|
5.7%
2/35 • Number of events 2 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
5.6%
2/36 • Number of events 2 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
|
General disorders
Vomit
|
0.00%
0/35 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
2.8%
1/36 • Number of events 1 • AE data were collected over the duration of the study (4 years).
All AE information that were collected were expected side effects of the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place