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Completed

NCT Number: NCT00667875

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of South Carolina, Center for Drug and Alcohol Programs

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 70
  • 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

  • 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)
  • 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
  • Able to read and understand questionnaires and informed consent
  • Lives within approximately 50 miles of the study site -

Exclusion criteria

  • Currently meets DSM IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
  • Ever abused opiates
  • Any psychoactive substance abuse, except marijuana and nicotine, within the last 30 days as evidenced by subject report, collateral report, or urine drug screen
  • 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
  • Meets DSM IV current criteria for dissociative disorder or eating disorders
  • Has current suicidal ideation or homicidal ideation
  • Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications
  • Current use of disulfiram
  • Clinically significant medical problems such as cardiovascular, renal, GI, or endocrine problem that would impair participation or limit medication ingestion
  • 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
  • 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
  • Has current charges pending for a violent crime (not including DUI-related offenses)
  • Does not have a stable living situation and a reliable source of collateral reporting
  • Has taken an opiate antagonist drug in the last month
  • Has taken aripiprazole in the last month or has experienced adverse effects from it at any time in the past

Treatment and study plan

Placebo

Drug

placebo

Naltrexone

Drug

Naltrexone (25mg or 50 mg per titration schedule)

Naltrexone + Aripiprazole

Drug

Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)

Primary outcomes

  1. Drinks Per Drinking Day

    Time frame: 16-week treatment period

    Standard drinks per drinking day

  2. 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 outcomes

  1. Pill Counts During Treatment

    Time frame: 16-week

    Compliance with medication as determined by pill counts

  2. 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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: NALAPZ

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 28, 2008
Registry last updated
Sep 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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