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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00667875
First received: April 24, 2008
Last updated: August 4, 2011
Last verified: December 2009

April 24, 2008
August 4, 2011
April 2008
May 2011   (final data collection date for primary outcome measure)
drinks per drinking day [ Time Frame: 16-week treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00667875 on ClinicalTrials.gov Archive Site
  • Pill counts and urinary riboflavin levels during treatment [ Time Frame: 16-week ] [ Designated as safety issue: No ]
  • Subject-reported adverse events on the SAFTEE interview [ Time Frame: 16-week ] [ Designated as safety issue: Yes ]
  • Percent heavy drinking days over the 16-week study [ Time Frame: 16-weeks ] [ Designated as safety issue: No ]
  • Urinary riboflavin levels during treatment [ Time Frame: 16-week ] [ Designated as safety issue: No ]
  • Subject-reported adverse events on the SAFTEE interview [ Time Frame: 16-week ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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
60
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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00667875
ANTON-1R21AA017525-01, R21AA017525, NIH Grant AA017525-01
Yes
Raymond F. Anton, M.D., 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
December 2009

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