NCT00382642

Brief Summary

The purpose of this study is to learn whether ondansetron is safe and effective in the treatment of alcohol dependence. We also want to learn whether the study drug ondansetron combined with Cognitive Behavioral Therapy will assist researchers to determine whether having a certain gene is responsible for determining how a person benefits or does not benefit from the use of ondansetron for alcohol dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
283

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2006

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 7, 2012

Status Verified

February 1, 2012

Enrollment Period

2.8 years

First QC Date

September 28, 2006

Last Update Submit

February 3, 2012

Conditions

Alcohol Dependence

Keywords

alcoholism, alcohol disorder, drinking,alcohol

Outcome Measures

Primary Outcomes (1)

  • Self-reported measure of alcohol consumption (Drinks per Day, Drinks per Drinking Day, Percent Days Abstinent), CDT (ondansetron level), GGT, BAC

    Throughout the study

Secondary Outcomes (1)

  • Pill count, CIWA-Ar, OCDS, Age of onset, SFQ, AASE, ADBS, CGI, TCI, MAC, attendace at psychosocial services

    Throughout the study

Study Arms (2)

Ondansetron

EXPERIMENTAL

Arm 1 = Ondansetron 4 mcg/kg b.i.d.+ Cognitive behavioral therapy

Drug: Ondansetron + Cognitive Behavioral Therapy

Placebo

PLACEBO COMPARATOR

Arm 2 = Placebo + Cognitive behavioral therapy

Drug: Placebo + Cognitive Behavioral Therapy

Interventions

Ondansetron + Cognitive Behavioral TherapyDRUG

13 week outpatient trial

Also known as: Zofran
Ondansetron
Placebo + Cognitive Behavioral TherapyDRUG

13 week outpatient trial

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
  • Audit score equal or more than 8
  • Current DSM-IV diagnosis of alcohol dependence
  • Currently drinking equal or more than 14 alcohol units/week for women and equal or more than 21 alcohol units/week for men in the last 30 days.
  • 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, and express a wish to stop drinking.
  • Willingness to participate in behavioral treatments for alcoholism.

You may not qualify if:

  • Subjects who are legally mandated to participate in an alcohol treatment program.
  • 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 ondansetron or similar medication either 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.
  • Members of the same household.
  • Treated with any medications having a potential effect on alcohol consumption and related behaviors, or mood. These include: opiate antagonist (e.g. naltrexone), glutamate antagonists (e.g., acamprosate), serotonin re-uptake inhibitors (e.g. fluoxetine), serotonin antagonists (e.g. ritanserin or buspirone), other antidepressants (e.g. tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g. haloperidol), calcium channel antagonists (e.g. isradipine), or compounds with actions similar to disulfiram (antabuse) or nicotine.
  • Before double-blind randomization, urine must be free of opiates, cocaine, amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UVA Center for Addiction Research and Education

Charlottesville, Virginia, 22911, United States

Location

Related Publications (1)

  • Johnson BA, Seneviratne C, Wang XQ, Ait-Daoud N, Li MD. Determination of genotype combinations that can predict the outcome of the treatment of alcohol dependence using the 5-HT(3) antagonist ondansetron. Am J Psychiatry. 2013 Sep;170(9):1020-31. doi: 10.1176/appi.ajp.2013.12091163.

    PMID: 23897038DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

OndansetronCognitive Behavioral TherapySugars

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesCarbohydrates

Study Officials

  • Bankole Johnson, M.D., Ph.D.

    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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chair of Psychiatry and NB Sciences

Study Record Dates

First Submitted

September 28, 2006

First Posted

September 29, 2006

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

February 7, 2012

Record last verified: 2012-02

Locations

US(1)