Combined Pharmacotherapies for Alcoholism

NCT00768508 | Completed Phase 3 DMC

• 2 other identifiers: 12790R01AA012964
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.

Conditions

Alcoholism

Keywords

Alcohol; Alcohol Dependence; Alcoholism

Outcome Measures

Primary Outcomes (1)

• Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption

  Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT

  Throughout the study

Secondary Outcomes (1)

• Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors

  Throughout the study

Study Arms (4)

Ondansetron

EXPERIMENTAL

Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Drug: Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Naltrexone

EXPERIMENTAL

Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Drug: Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Ondansetron + Naltrexone

EXPERIMENTAL

Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Drug: Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Placebo

PLACEBO COMPARATOR

Placebo + Cognitive Behavioral Therapy

Other: Placebo + Cognitive Behavioral Therapy

Interventions

Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy DRUG

Ondansetron 4 ug/kg b.i.d.for 12 weeks

Also known as: Zofran

Ondansetron

Naltrexone 50 mg/day + Cognitive Behavioral Therapy DRUG

Naltrexone 50 mg/day for 12 weeks

Also known as: Revia

Naltrexone

Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy DRUG

Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks

Also known as: Zofran and Revia

Ondansetron + Naltrexone

Placebo + Cognitive Behavioral Therapy OTHER

Placebo comparator

Also known as: sugar pill

Placebo

Eligibility Criteria

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

You may qualify if:

• Males and females who have given written informed consent.
• Ages 18 years and above and must weigh at least 40 kg and no more than 140 kg.

You may not qualify if:

• Current DSM-IV diagnosis of alcohol dependence
• AUDIT score of equal or more than 8.
• Currently drinking
• Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next three months.
• The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
• Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
• Answer an advertisement in the newspaper/radio/television, or be referred from a health care professional and express a wish to stop drinking.
• Willingness to participate in behavioral treatments for alcoholism.
• Any current axis I DSM IV psychiatric disorder other than alcohol or nicotine dependence
• Elevation of liver enzymes - (SGOT), serum glutamic pyruvic transaminase (SGPT), blood urea nitrogen (BUN), or lactate dehydrogenase (LDH) greater than four times the normal range, or clinically significant elevated direct bilirubin as deemed by the principal investigator.
• Severe alcohol withdrawal symptoms which in the physicians opinion requires inpatient treatment.
• Serious medical co-morbidity requiring medical intervention or close supervision, or any condition which can interfere with the receipt of ondansetron.
• Severe or life-threatening adverse reactions to medications in the past or during this clinical trial.
• Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
• Compelled to participate in an alcohol treatment program to maintain their liberty.

Sponsors & Collaborators

• Bankole Johnson: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

UVA CARE

Charlottesville, Virginia, 22911, United States

Location

UVA CARE Richmond

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ondansetron; Cognitive Behavioral Therapy; Naltrexone; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Carbohydrates

Study Officials

• Bankole Johnson, DSc,MD,PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Psychiatry and NB Sciences

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

US (2)