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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 Medical University of South Carolina:

Primary Outcome Measures:
  • drinks per drinking day [ Time Frame: 16-week treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Raymond F Anton, M.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Raymond F. Anton, M.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00667875     History of Changes
Other Study ID Numbers: ANTON-1R21AA017525-01, R21AA017525, NIH Grant AA017525-01
Study First Received: April 24, 2008
Last Updated: August 4, 2011
Health Authority: United States: Federal Government

Keywords provided by Medical University of South Carolina:
Alcohol Dependence
Alcoholism
Naltrexone
Aripiprazole
Substance Abuse

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Naltrexone
Aripiprazole
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 22, 2014