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Functional Neuroimaging of Alcoholism Vulnerability (PIT) (CTNA)

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ClinicalTrials.gov Identifier: NCT01585168
Recruitment Status : Completed
First Posted : April 25, 2012
Results First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: Memantine
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Family History Negative (FHN): Memantine, Then Placebo   Family History Negative (FHN): Placebo, Then Memantine   Family History Positive (FHP): Memantine, Then Placebo   Family History Positive (FHP): Placebo, Then Memantine
STARTED   18   18   16   19 
COMPLETED   15   17   15   18 
NOT COMPLETED   3   1   1   1 
Lost to Follow-up                3                1                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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 Negative (FHN) People who have no affected first- or second-degree relatives.
Total Total of all reporting groups

Baseline Measures
   Family History Positive (FHP)   Family History Negative (FHN)   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   36   71 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed   35   36   71 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      35 100.0%      36 100.0%      71 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age [1] 
[Units: Years]
Mean (Full Range)
     
Participants Analyzed   33   32   65 
   24.70 
 (18 to 34) 
 22.09 
 (19 to 27) 
 23.42 
 (18 to 34) 
[1] 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 [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   33   32   65 
Female      28  84.8%      20  62.5%      48  73.8% 
Male      5  15.2%      12  37.5%      17  26.2% 
[1] 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 [1] 
[Units: Participants]
     
United States       
Participants Analyzed   33   32   65 
United States   33   32   65 
[1] 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.


  Outcome Measures

1.  Primary:   Change in Blood Oxygenation Level Dependent (BOLD) Activation in the Amygdala During "Win" Monetary Incentive Delay (MID) Task Between Placebo and Study Medication   [ Time Frame: 4 hours post intervention on each study day, separated by 1 week to 1 month ]

2.  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   [ Time Frame: 4 hours post intervention on each study day, separated by 1 week to 1 month ]

3.  Secondary:   Change in Impulsive Behavior as Measured on the Balloon Analog Risk Task (BART) Computerized Task Between Placebo and Study Medication   [ Time Frame: 3 hours post intervention on each study day, separated by 1 week to 1 month ]

4.  Secondary:   Change in Impulsive Behavior as Measured on the Experimental Discounting Delay (EDT) Computerized Task Between Placebo and Study Medication   [ Time Frame: 3 hours post intervention on each study day, separated by 1 week to 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Godfrey Pearlson
Organization: Yale University
phone: (860) 545-7757
e-mail: Godfrey.Pearlson@hhchealth.org



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01585168     History of Changes
Other Study ID Numbers: 1106008650
First Submitted: April 23, 2012
First Posted: April 25, 2012
Results First Submitted: November 3, 2017
Results First Posted: May 25, 2018
Last Update Posted: May 25, 2018