Combined Pharmacotherapies for Alcoholism
Information source: University of Virginia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholism
Intervention: 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 (Drug); Placebo + Cognitive Behavioral Therapy (Other)
Phase: Phase 3
Sponsored by: Bankole Johnson
Official(s) and/or principal investigator(s):
Bankole Johnson, DSc,MD,PhD, Principal Investigator, Affiliation: University of Virginia
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.
Official title: Combined Pharmacotherapies for Alcoholism
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Secondary outcome: Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
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.
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 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
- 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
- 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
- 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
- Before double-blind randomization, urine must be free of opiates, cocaine,
amphetamines, barbiturates, benzodiazepines, prescription and non-prescription drugs.
- Pyrexia of unknown origin
Locations and Contacts
UVA CARE, Charlottesville, Virginia 22911, United States
UVA CARE Richmond, Richmond, Virginia 23294, United States
Starting date: September 2008
Last updated: March 14, 2013