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An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence (NALAPZ)

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:
NCT00667875
First received: April 24, 2008
Last updated: March 17, 2016
Last verified: March 2016
Results First Received: March 17, 2016  
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: Placebo
Drug: Naltrexone
Drug: Naltrexone + Aripiprazole

  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
Subjects were recruited from the community in response to advertising in local papers, and radio

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were to remain abstinent for 4 days prior to starting treatment with the randomly assigned study drug.

Reporting Groups
  Description
1 Placebo Placebo : placebo
2 Naltrexone

Naltrexone

Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)

3 Naltrexone Plus Aripiprazole

Naltrexone + Aripiprazole

Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)


Participant Flow:   Overall Study
    1 Placebo   2 Naltrexone   3 Naltrexone Plus Aripiprazole
STARTED   23 [1]   21   21 [2] 
COMPLETED   13 [3]   10   8 
NOT COMPLETED   10   11   13 
Adverse Event                0                2                6 
Withdrawal by Subject                10                9                7 
[1] 3 subjects had no data after randomization and were excluded from analysis
[2] 2 subjects had no data following randomization and were excluded from the analysis.
[3] Subjects who dropped out during treatment are considered completed if they provide end of study 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
1 Placebo Placebo : placebo
2 Naltrexone

Naltrexone

Naltrexone : Naltrexone (25mg or 50 mg per titration schedule)

3 Naltrexone Plus Aripiprazole

Naltrexone + Aripiprazole

Naltrexone + Aripiprazole : Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

Total Total of all reporting groups

Baseline Measures
   1 Placebo   2 Naltrexone   3 Naltrexone Plus Aripiprazole   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   21   21   65 
Age 
[Units: Years]
Mean (Standard Deviation)
 47  (9.6)   47.2  (11.3)   48.4  (10.2)   47.6  (10.2) 
Gender 
[Units: Participants]
       
Female   7   7   9   23 
Male   16   14   12   42 


  Outcome Measures

1.  Primary:   Drinks Per Drinking Day   [ Time Frame: 16-week treatment period ]

2.  Secondary:   Pill Counts and Urinary Riboflavin Levels During Treatment   [ Time Frame: 16-week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Subject-reported Adverse Events on the SAFTEE Interview   [ Time Frame: 16-week ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Percent Heavy Drinking Days Over the 16-week Study   [ Time Frame: 16-weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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



Responsible Party: Raymond F. Anton, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00667875     History of Changes
Other Study ID Numbers: ANTON-1R21AA017525-01
R21AA017525 ( US NIH Grant/Contract Award Number )
NIH Grant AA017525-01
Study First Received: April 24, 2008
Results First Received: March 17, 2016
Last Updated: March 17, 2016
Health Authority: United States: Federal Government