An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

NCT00667875 | Completed Phase 2 Results DMC

• 3 other identifiers: ANTON-1R21AA017525-01R21AA017525NIH Grant AA017525-01
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Dependence

Keywords

Alcohol Dependence; Alcoholism; Naltrexone; Aripiprazole; Substance Abuse

Outcome Measures

Primary Outcomes (2)

• Drinks Per Drinking Day

  Standard drinks per drinking day

  16-week treatment period

• Percent Heavy Drinking Days

  percent of total 112 day trial in which heavy drinking occurred (\>=4 for females, \>=5 male)

  16 weeks

Secondary Outcomes (2)

• Pill Counts During Treatment

  16-week

• Percent Riboflavin Positive Urine Samples as a Measure of Medication Compliance

  16 weeks treatment trial

Study Arms (3)

1

PLACEBO COMPARATOR

Drug: Placebo

2

ACTIVE COMPARATOR

Naltrexone

Drug: Naltrexone

3

ACTIVE COMPARATOR

Naltrexone + Aripiprazole

Drug: Naltrexone + Aripiprazole

Interventions

Placebo DRUG

placebo

1

Naltrexone DRUG

Naltrexone (25mg or 50 mg per titration schedule)

2

Naltrexone + Aripiprazole DRUG

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

3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

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

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Interventions

Naltrexone; Aripiprazole

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Raymond F. Anton, MD
• Organization: Medical University of South Carolina

antonr@musc.edu

843-792-1226

Study Officials

• Raymond F Anton, M.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distringuished University Professor

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 28, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 29, 2017
• Results First Posted: April 18, 2016

Record last verified: 2017-08

Locations

US (1)