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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
April 24, 2008
April 28, 2008
March 17, 2016
April 18, 2016
September 29, 2017
April 2008
May 2011   (Final data collection date for primary outcome measure)
  • Drinks Per Drinking Day [ Time Frame: 16-week treatment period ]
    Standard drinks per drinking day
  • Percent Heavy Drinking Days [ Time Frame: 16 weeks ]
    percent of total 112 day trial in which heavy drinking occurred (>=4 for females, >=5 male)
Drinks Per Drinking Day [ Time Frame: 16-week treatment period ]
Complete list of historical versions of study NCT00667875 on ClinicalTrials.gov Archive Site
  • Pill Counts During Treatment [ Time Frame: 16-week ]
    Compliance with medication as determined by pill counts
  • Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance [ Time Frame: 16 weeks treatment trial ]
    Riboflavin was added to each individual capsule of medication and measured as a proxy for compliance with the medication regime
  • Urinary riboflavin levels during treatment [ Time Frame: 16-week ]
  • Subject-reported Adverse Events on the SAFTEE Interview [ Time Frame: 16-week ]
Not Provided
Not Provided
 
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence
The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: Placebo
    placebo
  • Drug: Naltrexone
    Naltrexone (25mg or 50 mg per titration schedule)
  • Drug: Naltrexone + Aripiprazole
    Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)
  • Placebo Comparator: 1
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Naltrexone
    Intervention: Drug: Naltrexone
  • Active Comparator: 3
    Naltrexone + Aripiprazole
    Intervention: Drug: Naltrexone + Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
May 2011
May 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 70
  2. Subjects will meet criteria for primary alcohol dependence operationalized as follows:

    A. Meets the DSM IV criteria for alcohol dependence including loss of control over drinking (criterion 3) B. Has not had more than one previous inpatient medical detoxification

  3. Consumes, on average, at least 10 standard drinks per drinking day for men and 8 drinks per day for women in the 90 days pre-screening (to select an appropriately heavy drinking population)
  4. Able to maintain sobriety for four days (with or without the aid of alcohol detoxification medications) as determined by self report, collateral report, and breathalyzer measurements
  5. Able to read and understand questionnaires and informed consent
  6. Lives within approximately 50 miles of the study site -

Exclusion Criteria:

  1. Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
  2. Ever abused opiates
  3. Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
  4. Meets DSM IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder
  5. Meets DSM IV current criteria for dissociative disorder or eating disorders
  6. Has current suicidal ideation or homicidal ideation
  7. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
  8. Current use of disulfiram
  9. Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
  10. Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days abstinence
  11. Sexually active female of child-bearing potential who is pregnant (by urine HCG), nursing, or who is not using a reliable form of birth control
  12. Has current charges pending for a violent crime (not including DUI-related offenses)
  13. Does not have a stable living situation and a reliable source of collateral reporting
  14. Has taken an opiate antagonist drug in the last month
  15. Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00667875
ANTON-1R21AA017525-01
R21AA017525 ( U.S. NIH Grant/Contract )
NIH Grant AA017525-01
Yes
Not Provided
Not Provided
Raymond F. Anton, Medical University of South Carolina
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Raymond F Anton, M.D. Medical University of South Carolina
Medical University of South Carolina
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP