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Combined Pharmacotherapies for Alcoholism

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ClinicalTrials.gov Identifier: NCT00768508
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : March 15, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy Drug: Naltrexone 50 mg/day + Cognitive Behavioral Therapy Drug: Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy Other: Placebo + Cognitive Behavioral Therapy Phase 3

Detailed Description:
We propose to conduct a 13 week randomized, controlled clinical trial to evaluate the safety and efficacy of ondansetron and naltrexone alone and in combination.Eligible subjects will be randomized to placebo, ondansetron, naltrexone, or ondansetron + naltrexone treatments. All subjects will receive a weekly CBT (Cognitive Behavioral Therapy)sessions.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Pharmacotherapies for Alcoholism
Study Start Date : September 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ondansetron
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Drug: Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Ondansetron 4 ug/kg b.i.d.for 12 weeks
Other Name: Zofran
Experimental: Naltrexone
Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Drug: Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Naltrexone 50 mg/day for 12 weeks
Other Name: Revia
Experimental: Ondansetron + Naltrexone
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
Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks
Other Name: Zofran and Revia
Placebo Comparator: Placebo
Placebo + Cognitive Behavioral Therapy
Other: Placebo + Cognitive Behavioral Therapy
Placebo comparator
Other Name: sugar pill

Outcome Measures

Primary Outcome Measures :
  1. Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption [ Time Frame: Throughout the study ]
    Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT

Secondary Outcome Measures :
  1. Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors [ Time Frame: Throughout the study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 (see exclusion criteria).
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  • Concurrent treatment 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. tricylic 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.
  • Pyrexia of unknown origin
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768508

United States, Virginia
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Bankole Johnson
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Bankole Johnson, DSc,MD,PhD University of Virginia
More Information

Responsible Party: Bankole Johnson, Chair of Psychiatry and NB Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT00768508     History of Changes
Other Study ID Numbers: 12790
R01AA012964 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

Keywords provided by Bankole Johnson, University of Virginia:
Alcohol Dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents