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Combined Pharmacotherapies for Alcoholism
This study is currently recruiting participants.
Verified by University of Virginia, January 2010
First Received: October 6, 2008   Last Updated: January 19, 2010   History of Changes
Sponsor: University of Virginia
Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by: University of Virginia
ClinicalTrials.gov Identifier: NCT00768508
  Purpose

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 Intervention Phase
Alcoholism
Drug: Ondansetron
Drug: Naltrexone
Drug: Ondansetron + Naltrexone
Other: Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: Combined Pharmacotherapies for Alcoholism

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • EOA, compared with LOA, will be more responsive to treatment with either ondansetron or naltrexone alone. The combination of ondansetron and naltrexone will be superior to either medication alone in the treatment of EOA. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The combination of ondansetron and naltrexone will be better tolerated than naltrexone alone. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: September 2008
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ondansetron: Experimental
Ondansetron 4 ug/kg b.i.d.),
Drug: Ondansetron
Ondansetron 4 ug/kg b.i.d.),
Naltrexone: Experimental
Naltrexone 50 mg/day
Drug: Naltrexone
Naltrexone 50 mg/day
Ondansetron + Naltrexone: Experimental
Combination of Ondansetron 4 ug/kg bid and Naltrexone 50 mg/day
Drug: Ondansetron + Naltrexone
Combination of ondansetron and naltrexone
Placebo: Placebo Comparator Other: Placebo
Placebo comparator

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768508

Contacts
Contact: Mindy Borszich, B.A. 1-888-882-2345 uvacare@virginia.edu

Locations
United States, Virginia
UVA CARE Recruiting
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond Recruiting
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Bankole Johnson, DSc,MD,PhD University of Virginia
  More Information

No publications provided

Responsible Party: University of Virginia ( Bankole Johnson )
Study ID Numbers: 12790, R01 AA012964
Study First Received: October 6, 2008
Last Updated: January 19, 2010
ClinicalTrials.gov Identifier: NCT00768508     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
Alcohol
Alcohol Dependence
Alcoholism

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Narcotic Antagonists
Psychotropic Drugs
Disorders of Environmental Origin
Antiemetics
Serotonin Antagonists
Sensory System Agents
Mental Disorders
Therapeutic Uses
Substance-Related Disorders
Antipruritics
Alcohol-Related Disorders
Ondansetron
Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Naltrexone
Alcoholism
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010