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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
  Purpose
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.

Condition Intervention Phase
Alcohol Dependence Drug: Placebo Drug: Naltrexone Drug: Naltrexone + Aripiprazole Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by Raymond F. Anton, Medical University of South Carolina:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 65
Study Start Date: April 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
placebo
Active Comparator: 2
Naltrexone
Drug: Naltrexone
Naltrexone (25mg or 50 mg per titration schedule)
Active Comparator: 3
Naltrexone + Aripiprazole
Drug: Naltrexone + Aripiprazole
Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667875


Locations
United States, South Carolina
Medical University of South Carolina, Center for Drug and Alcohol Programs
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Raymond F Anton, M.D. Medical University of South Carolina
  More Information

Responsible Party: Raymond F. Anton, Distringuished University Professor, 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
Last Verified: August 2017

Keywords provided by Raymond F. Anton, Medical University of South Carolina:
Alcohol Dependence
Alcoholism
Naltrexone
Aripiprazole
Substance Abuse

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Aripiprazole
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs