The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier:
NCT00896038
First received: May 8, 2009
Last updated: October 5, 2015
Last verified: October 2015
Results First Received: May 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Alcoholism
Alcohol Dependence
Posttraumatic Stress Disorder
Interventions: Drug: Aprepitant
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Aprepitant Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
Placebo Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days

Participant Flow:   Overall Study
    Aprepitant     Placebo  
STARTED     30     28  
COMPLETED     26     27  
NOT COMPLETED     4     1  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Aprepitant Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
Placebo Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
Total Total of all reporting groups

Baseline Measures
    Aprepitant     Placebo     Total  
Number of Participants  
[units: participants]
  30     28     58  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     28     58  
>=65 years     0     0     0  
Gender  
[units: Participants]
     
Female     14     13     27  
Male     16     15     31  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     2     2  
Not Hispanic or Latino     30     26     56  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     14     14     28  
White     16     12     28  
More than one race     0     0     0  
Unknown or Not Reported     0     1     1  



  Outcome Measures
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1.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

2.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 5 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

3.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 15 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

4.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 30 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

5.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 45 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

6.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 60 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

7.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 75 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

8.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 90 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

9.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 15 minutes prior to the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

10.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 5 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

11.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 15 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

12.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 30 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

13.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 45 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

14.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 60 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

15.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 75 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

16.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 90 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 of the treatment period ]

17.  Primary:   PTSD Total Symptom Severity Score   [ Time Frame: Day 29 of the treatment period, 2 days after the final script presentation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Melanie Schwandt
Organization: National Institute on Alcohol Abuse and Alcoholism
phone: 3014516960
e-mail: melanies@mail.nih.gov


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier: NCT00896038     History of Changes
Other Study ID Numbers: 090136
09-AA-0136 ( Other Identifier: NIHCC )
Study First Received: May 8, 2009
Results First Received: May 26, 2015
Last Updated: October 5, 2015
Health Authority: United States: Federal Government
United States: Food and Drug Administration