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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00183196
First received: September 13, 2005
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Participant, Care Provider, 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
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.

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 
Overall Participants Analyzed 
[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
No text entered.


  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 ( U.S. NIH Grant/Contract )
NIH RO1 AA09568
Study First Received: September 13, 2005
Results First Received: November 20, 2012
Last Updated: March 17, 2016