Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00183196
First received: September 13, 2005
Last updated: April 23, 2013
Last verified: January 2013
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alcohol Dependence
Interventions: Drug: Naltrexone
Drug: Naltrexone plus Gabapentin
Other: Inactive 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
No text entered.

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
Naltrexone Plus Gabapentin and CBI Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
Naltrexone Plus Placebo and CBI Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
Placebo Plus Placebo Plus CBI Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.

Participant Flow:   Overall Study
    Naltrexone Plus Gabapentin and CBI     Naltrexone Plus Placebo and CBI     Placebo Plus Placebo Plus CBI  
STARTED     50 [1]   50 [2]   50 [2]
COMPLETED     30     35     32  
NOT COMPLETED     20     15     18  
Withdrawal by Subject                 18                 11                 13  
Adverse Event                 1                 2                 2  
Legal event                 1                 1                 1  
Required more intensive care                 0                 1                 2  
[1] 2 subjects had no post-randomization data
[2] 1 subject had no post-randomization data



  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.
No text entered.

Reporting Groups
  Description
Naltrexone Plus Gabapentin and CBI Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
Naltrexone Plus Placebo and CBI Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
Placebo Plus Placebo Plus CBI Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
Total Total of all reporting groups

Baseline Measures
    Naltrexone Plus Gabapentin and CBI     Naltrexone Plus Placebo and CBI     Placebo Plus Placebo Plus CBI     Total  
Number of Participants  
[units: participants]
  50     50     50     150  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     50     49     49     148  
>=65 years     0     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 9.8     44.4  ± 10.1     46.6  ± 9.0     44.6  ± 9.7  
Gender  
[units: participants]
       
Female     10     11     10     31  
Male     40     39     40     119  
Region of Enrollment  
[units: participants]
       
United States     50     50     50     150  



  Outcome Measures

1.  Primary:   Time to Relapse to Drinking   [ Time Frame: 16 weeks ]


  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:  
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, MD
Organization: Medical University of South Carolina
phone: 843-792-1226
e-mail: antonr@musc.edu


Publications of Results:

Responsible Party: Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00183196     History of Changes
Other Study ID Numbers: NIAAAANT09568-2005a, 5R01AA009568-14, NIH RO1 AA09568
Study First Received: September 13, 2005
Results First Received: November 20, 2012
Last Updated: April 23, 2013
Health Authority: United States: Federal Government