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CRF1 Antagonist GSK561679 in Alcoholism

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:
NCT01187511
First received: August 21, 2010
Last updated: September 19, 2016
Last verified: September 2016
Results First Received: September 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Dependence
Interventions: Drug: GSK561679
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
GSK561679 GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679

Participant Flow:   Overall Study
    GSK561679   Placebo
STARTED   22   22 
COMPLETED   14   21 
NOT COMPLETED   8   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
GSK561679 GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
Placebo Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
Total Total of all reporting groups

Baseline Measures
   GSK561679   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   22   44 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   22   22   44 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   22   22   44 
Male   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
Not Hispanic or Latino   21   22   43 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   5   12   17 
White   16   10   26 
More than one race   0   0   0 
Unknown or Not Reported   1   0   1 


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

17.  Secondary:   Alcohol Craving in Response to the Trier/Cue-reactivity Procedure   [ Time Frame: 100 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period ]

18.  Secondary:   Alcohol Craving in Response to the Trier/Cue-reactivity Procedure   [ Time Frame: 15 minutes prior to the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period ]

19.  Secondary:   Alcohol Craving in Response to the Trier/Cue-reactivity Procedure   [ Time Frame: 20 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period ]

20.  Secondary:   Alcohol Craving in Response to the Trier/Cue-reactivity Procedure   [ Time Frame: 40 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period ]

21.  Secondary:   Alcohol Craving in Response to the Trier/Cue-reactivity Procedure   [ Time Frame: 70 minutes after the beginning of the Trier/cue-reactivity procedure, which occurred on Day 21 of the treatment period ]

22.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 1 of the treatment period ]

23.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 11 of the treatment period ]

24.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 14 of the treatment period ]

25.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 18 of the treatment period ]

26.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 21 of the treatment period ]

27.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 25 of the treatment period ]

28.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 28 of the treatment period ]

29.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 32 of the treatment period ]

30.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 4 of the treatment period ]

31.  Secondary:   Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 7 of the treatment period ]

32.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 1 of the treatment period ]

33.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 11 of the treatment period ]

34.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 14 of the treatment period ]

35.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 18 of the treatment period ]

36.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 21 of the treatment period ]

37.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 25 of the treatment period ]

38.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 28 of the treatment period ]

39.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 32 of the treatment period ]

40.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 4 of the treatment period ]

41.  Secondary:   Depression Symptom Ratings Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 7 of the treatment period ]

42.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 1 of the treatment period ]

43.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 11 of the treatment period ]

44.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 14 of the treatment period ]

45.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 18 of the treatment period ]

46.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 21 of the treatment period ]

47.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 25 of the treatment period ]

48.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 28 of the treatment period ]

49.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 32 of the treatment period ]

50.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 4 of the treatment period ]

51.  Secondary:   Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period   [ Time Frame: Day 7 of the treatment period ]


  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: Leggio, Lorenzo
Organization: National Institute on Alcohol Abuse and Alcoholism
phone: +1 301 435 9398
e-mail: lorenzo.leggio@nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier: NCT01187511     History of Changes
Other Study ID Numbers: 100046
10-AA-0046 ( Other Identifier: NIH )
Study First Received: August 21, 2010
Results First Received: September 19, 2016
Last Updated: September 19, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration