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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667875
First Posted: April 28, 2008
Last Update Posted: September 29, 2017
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.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Raymond F. Anton, Medical University of South Carolina
Results First Submitted: March 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, 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] 
Subjects Included in Analysisd   20   21   19 
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      7  30.4%      7  33.3%      9  42.9%      23  35.4% 
Male      16  69.6%      14  66.7%      12  57.1%      42  64.6% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Primary:   Percent Heavy Drinking Days   [ Time Frame: 16 weeks ]

3.  Secondary:   Pill Counts During Treatment   [ Time Frame: 16-week ]

4.  Secondary:   Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance   [ Time Frame: 16 weeks treatment trial ]


  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 ( U.S. NIH Grant/Contract )
NIH Grant AA017525-01
First Submitted: April 24, 2008
First Posted: April 28, 2008
Results First Submitted: March 17, 2016
Results First Posted: April 18, 2016
Last Update Posted: September 29, 2017