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Trial record 17 of 39 for:    FLUMAZENIL

Prometa Protocol for Alcohol Dependence

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: NCT00262639
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : August 14, 2009
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Dependence
Interventions Drug: Flumazenil and Gabapentin
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Hide Arm/Group Description 2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39. 20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39. 20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39. 2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
Period Title: Overall Study
Started 18 26 9 7
Completed 18 26 9 7
Not Completed 0 0 0 0
Arm/Group Title Low CIWAar Placebo Low CIWAar Flumazenil/Gabapentin High CIWAar Placebo High CIWAar Flumazenil/Gabapentin Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 18 26 9 7 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 26 participants 9 participants 7 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
26
 100.0%
9
 100.0%
7
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 26 participants 9 participants 7 participants 60 participants
47.2  (11.2) 44.1  (11.9) 50.3  (8.5) 46.7  (5.6) 46.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 26 participants 9 participants 7 participants 60 participants
Female
4
  22.2%
6
  23.1%
3
  33.3%
1
  14.3%
14
  23.3%
Male
14
  77.8%
20
  76.9%
6
  66.7%
6
  85.7%
46
  76.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 26 participants 9 participants 7 participants 60 participants
18 26 9 7 60
1.Primary Outcome
Title Percent Subjects Completely Abstinent
Hide Description percent of subjects completely abstinent during the six week medication study study
Time Frame 6 week trial
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Hide Arm/Group Description:
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
Overall Number of Participants Analyzed 18 26 9 7
Measure Type: Number
Unit of Measure: percent of participants
44 19 33 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low CIWA Flumazenil/Gabapentin, Low CIWAar Placebo, High CIWAar Placebo, High CIWAar Flumazenil/Gabapentin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
2.Primary Outcome
Title Percent Days Abstinent
Hide Description percent days abstinent during treatment
Time Frame Weeks 1 to 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Hide Arm/Group Description:
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
Overall Number of Participants Analyzed 18 26 9 7
Mean (Standard Deviation)
Unit of Measure: percent days
70.8  (24.2) 86.1  (20.7) 75.9  (27) 95.9  (9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low CIWA Flumazenil/Gabapentin, Low CIWAar Placebo, High CIWAar Placebo, High CIWAar Flumazenil/Gabapentin
Comments The analysis was an ANOVA interaction analysis with alcohol withdrawal (AW) group (Low vs. High) by medication group (active versus placebo medication) across the 6 weeks of the medication trial.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments This p value is for the interaction of AW status by medication group.
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Hide Arm/Group Description 2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39. 20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39. 20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39. 2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
All-Cause Mortality
Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/26 (0.00%)   0/9 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low CIWA Flumazenil/Gabapentin Low CIWAar Placebo High CIWAar Placebo High CIWAar Flumazenil/Gabapentin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/26 (0.00%)   0/9 (0.00%)   0/7 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Raymond F. Anton, M.D.
Organization: Medical University of South Carolina
Phone: 843-792-1226
EMail: antonr@musc.edu
Layout table for additonal information
Responsible Party: Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00262639     History of Changes
Other Study ID Numbers: 15844
First Submitted: December 5, 2005
First Posted: December 7, 2005
Results First Submitted: July 6, 2009
Results First Posted: August 14, 2009
Last Update Posted: February 15, 2019