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
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Period Title: Overall Study
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
Arm/Group Title Pexacerfont Placebo Total
Hide Arm/Group Description Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days Total of all reporting groups
Overall Number of Baseline Participants 40 30 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 70 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
 100.0%
30
 100.0%
70
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 70 participants
Female
6
  15.0%
5
  16.7%
11
  15.7%
Male
34
  85.0%
25
  83.3%
59
  84.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 70 participants
Hispanic or Latino
2
   5.0%
0
   0.0%
2
   2.9%
Not Hispanic or Latino
38
  95.0%
30
 100.0%
68
  97.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 30 participants 70 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.5%
1
   3.3%
2
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
20
  50.0%
19
  63.3%
39
  55.7%
White
16
  40.0%
9
  30.0%
25
  35.7%
More than one race
1
   2.5%
0
   0.0%
1
   1.4%
Unknown or Not Reported
2
   5.0%
1
   3.3%
3
   4.3%
1.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: Units on a scale
12.7  (2.48) 10.7  (2.60)
2.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
18.7  (2.48) 14.5  (2.6)
3.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: Units on a scale
16.6  (2.48) 12.9  (2.6)
4.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
16.5  (2.48) 11.8  (2.6)
5.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
15  (2.48) 12.1  (2.6)
6.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
13.7  (2.48) 12.3  (2.6)
7.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
13.5  (2.48) 12  (2.6)
8.Primary Outcome
Title Alcohol Craving in Response to the Alcohol Cue Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
13.7  (2.48) 11.7  (2.6)
9.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
12.9  (2.61) 10.2  (2.74)
10.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
17.8  (2.61) 14.4  (2.74)
11.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
16.8  (2.61) 12.5  (2.74)
12.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
15.3  (2.61) 12.2  (2.74)
13.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
14.9  (2.61) 11.6  (2.74)
14.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
14.3  (2.61) 11.6  (2.74)
15.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: units on a scale
14.9  (2.61) 11.7  (2.74)
16.Primary Outcome
Title Alcohol Craving in Response to the Stress Script
Hide Description Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).
Time Frame 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description:
Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Number of Participants Analyzed 26 25
Mean (Standard Error)
Unit of Measure: Units on a scale
14.6  (2.61) 11.2  (2.74)
Time Frame Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pexacerfont Placebo
Hide Arm/Group Description Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
All-Cause Mortality
Pexacerfont Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pexacerfont Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pexacerfont Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   34/40 (85.00%)   28/30 (93.33%) 
Gastrointestinal disorders     
Abdominal pain   2/40 (5.00%)  0/30 (0.00%) 
Nausea   9/40 (22.50%)  11/30 (36.67%) 
Toothache   0/40 (0.00%)  2/30 (6.67%) 
Vomiting   3/40 (7.50%)  2/30 (6.67%) 
General disorders     
Fatigue   29/40 (72.50%)  24/30 (80.00%) 
Musculoskeletal and connective tissue disorders     
Back Pain   0/40 (0.00%)  3/30 (10.00%) 
Pain in extremity   2/40 (5.00%)  3/30 (10.00%) 
Nervous system disorders     
Dizziness   7/40 (17.50%)  6/30 (20.00%) 
Headache   23/40 (57.50%)  23/30 (76.67%) 
Memory impairment   0/40 (0.00%)  2/30 (6.67%) 
Nervous system disorders - Other, specify   0/40 (0.00%)  2/30 (6.67%) 
Psychiatric disorders     
Anxiety   2/40 (5.00%)  3/30 (10.00%) 
Insomnia   2/40 (5.00%)  0/30 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Nasal congestion   2/40 (5.00%)  0/30 (0.00%) 
Sore throat   10/40 (25.00%)  8/30 (26.67%) 
Skin and subcutaneous tissue disorders     
Skin and subcutaneous tissue disorders - Other, specify   0/40 (0.00%)  3/30 (10.00%) 
Indicates events were collected by systematic assessment
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
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