We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    17019567 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01227980
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : December 10, 2015
Last Update Posted : February 2, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Alcohol-Related Disorders
Alcohol Dependence
Alcoholism
Anxiety Disorder
Interventions: Drug: Pexacerfont
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
No text entered.

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
Pexacerfont Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Placebo Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days

Participant Flow:   Overall Study
    Pexacerfont   Placebo
STARTED   40   30 
Scripts Challenge Sessions   26   25 
Measure Drug Level Concentration   10   0 [1] 
COMPLETED   38 [2]   25 
NOT COMPLETED   2   5 
[1] No placebo subjects completed this milestone which measured active drug levels
[2] Two subjects did not complete the scripts sessions but completed the remainder of the protocol



  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
Pexacerfont Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Placebo Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Total Total of all reporting groups

Baseline Measures
   Pexacerfont   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   30   70 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   40   30   70 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   6   5   11 
Male   34   25   59 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   2   0   2 
Not Hispanic or Latino   38   30   68 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   20   19   39 
White   16   9   25 
More than one race   1   0   1 
Unknown or Not Reported   2   1   3 


  Outcome Measures

1.  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 24, 25, or 26 of the treatment period ]

2.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

3.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

4.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

5.  Primary:   Alcohol Craving in Response to the Alcohol Cue Script   [ Time Frame: 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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 24, 25, or 26 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 24, 25, or 26 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 24, 25, or 26 of the treatment period ]

9.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

10.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

11.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

12.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period ]

13.  Primary:   Alcohol Craving in Response to the Stress Script   [ Time Frame: 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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 24, 25, or 26 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 24, 25, or 26 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 24, 25, or 26 of the treatment period ]


  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:  
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: 301-451-6960
e-mail: melanies@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier: NCT01227980     History of Changes
Other Study ID Numbers: 110010
11-AA-0010 ( Other Identifier: NIH )
First Submitted: October 22, 2010
First Posted: October 25, 2010
Results First Submitted: November 4, 2015
Results First Posted: December 10, 2015
Last Update Posted: February 2, 2016