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Trial record 16 of 36 for:    flumazenil

Prometa Protocol for Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT00262639
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : August 14, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
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

  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
Low CIWA Flumazenil/Gabapentin 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.
Low CIWAar Placebo 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.
High CIWAar Placebo 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.
High CIWAar Flumazenil/Gabapentin 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.

Participant Flow:   Overall Study
    Low CIWA Flumazenil/Gabapentin   Low CIWAar Placebo   High CIWAar Placebo   High CIWAar Flumazenil/Gabapentin
STARTED   18   26   9   7 
COMPLETED   18   26   9   7 
NOT COMPLETED   0   0   0   0 



  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
Low CIWAar Placebo No text entered.
Low CIWAar Flumazenil/Gabapentin No text entered.
High CIWAar Placebo No text entered.
High CIWAar Flumazenil/Gabapentin No text entered.
Total Total of all reporting groups

Baseline Measures
   Low CIWAar Placebo   Low CIWAar Flumazenil/Gabapentin   High CIWAar Placebo   High CIWAar Flumazenil/Gabapentin   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   26   9   7   60 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   18   26   9   7   60 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.2  (11.2)   44.1  (11.9)   50.3  (8.5)   46.7  (5.6)   46.1  (10.6) 
Gender 
[Units: Participants]
         
Female   4   6   3   1   14 
Male   14   20   6   6   46 
Region of Enrollment 
[Units: Participants]
         
United States   18   26   9   7   60 


  Outcome Measures

1.  Primary:   Percent Subjects Completely Abstinent   [ Time Frame: 16 week trial ]

2.  Primary:   Percent Days Abstinent   [ Time Frame: Weeks 1 to 6, 10 and 14 ]

3.  Primary:   Alcohol Withdrawal Scores (CIWAar)   [ Time Frame: Day 1 Day 2 Week 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Sleep   [ Time Frame: Weeks 1 to 6, 10 and 14 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Acoustic Startle Response   [ Time Frame: Day 1, Day 3, Week 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Regional Brain Activity on fMRI   [ Time Frame: Week 2 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
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:  
Name/Title: Raymond F. Anton, M.D.
Organization: Medical University of South Carolina
phone: 843-792-1226
e-mail: antonr@musc.edu



Responsible Party: Raymond F. Anton, MD, 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: December 15, 2009