Combined Pharmacotherapies for Alcoholism

Condition(s) targeted: Alcoholism

Intervention: Ondansetron (Drug); Naltrexone (Drug); Ondansetron + Naltrexone (Drug); Placebo (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Virginia

Official(s) and/or principal investigator(s):
Bankole Johnson, DSc,MD,PhD, Principal Investigator, Affiliation: University of Virginia

Overall contact:
Mindy Borszich, B.A., Phone: 1-888-882-2345, Email: uvacare@virginia.edu

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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: The combination of ondansetron and naltrexone will be better tolerated than naltrexone alone.

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

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

UVA CARE, Charlottesville, Virginia 22911, United States; Recruiting

UVA CARE Richmond, Richmond, Virginia 23294, United States; Recruiting

Starting date: September 2008
Ending date: January 2012
Last updated: September 3, 2009