Pharmacological Treatment for Alcoholism

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT00382642
First received: September 28, 2006
Last updated: February 3, 2012
Last verified: February 2012

September 28, 2006
February 3, 2012
June 2006
March 2009   (final data collection date for primary outcome measure)
Self-reported measure of alcohol consumption (Drinks per Day, Drinks per Drinking Day, Percent Days Abstinent), CDT (ondansetron level), GGT, BAC [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Self-reported measure of alcohol consumptionSelf-reported measure of alcohol consumption (Drinks per Day, Drinks per Drinking Day, Percent Days Abstinent), GGT and serum CDT level an objective marker of transient alcohol consumption.
Complete list of historical versions of study NCT00382642 on ClinicalTrials.gov Archive Site
Pill count, CIWA-Ar, OCDS, Age of onset, SFQ, AASE, ADBS, CGI, TCI, MAC, attendace at psychosocial services [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
medication compliance, withdrawal, alcohol craving, social functioning and motivation
Social functioning, self-efficacy and motivation to use alcohol,subjective measures of alcohol craving, medication compliance.
Not Provided
Not Provided
 
Pharmacological Treatment for Alcoholism
Pharmacological Treatment for Alcoholism

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.

This is a 13 week outpatient clinical trial. Participants will either receive ondansetron or placebo and behavioral therapy. There is a 1, 2, and 3 month post-study follow up visit.Screening for this study is initially done over the telephone and takes 15-20 minutes. If participants are eligible after the initial screen, they will be invited to come in for a more thorough in house screen which takes about 5 to 6 hours. The screening will include a physical exam, review of medical, alcohol and drug histories and blood collection. If participants are found to be eligible after the in house screen, they will be enrolled in the 13 week outpatient clinical trial.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alcohol Dependence
  • Drug: Ondansetron + Cognitive Behavioral Therapy
    13 week outpatient trial
    Other Name: Zofran
  • Drug: Placebo + Cognitive Behavioral Therapy
    13 week outpatient trial
    Other Name: Sugar Pill
  • Experimental: Ondansetron
    Arm 1 = Ondansetron 4 mcg/kg b.i.d.+ Cognitive behavioral therapy
    Intervention: Drug: Ondansetron + Cognitive Behavioral Therapy
  • Placebo Comparator: Placebo
    Arm 2 = Placebo + Cognitive behavioral therapy
    Intervention: Drug: Placebo + Cognitive Behavioral Therapy
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 1;170(9):1020-31. doi: 10.1176/appi.ajp.2013.12091163.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
283
December 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Received inpatient or outpatient treatment for alcohol dependence within the last 30 days (support groups such as AA are not exclusionary).
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00382642
R01AA10522-11, R01AA010522
Yes
Bankole Johnson, University of Virginia
Bankole Johnson
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Bankole Johnson, M.D., Ph.D. University of Virginia
University of Virginia
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP