Combined Pharmacotherapies for Alcoholism

NCT ID: NCT00768508

Last Updated: 2013-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Alcoholism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ondansetron

Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Intervention Type: DRUG

Ondansetron 4 ug/kg b.i.d.for 12 weeks

Naltrexone

Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Intervention Type: DRUG

Naltrexone 50 mg/day for 12 weeks

Ondansetron + Naltrexone

Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Group Type: EXPERIMENTAL

Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Intervention Type: DRUG

Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks

Placebo

Placebo + Cognitive Behavioral Therapy

Group Type: PLACEBO_COMPARATOR

Placebo + Cognitive Behavioral Therapy

Intervention Type: OTHER

Placebo comparator

Interventions

Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy

Ondansetron 4 ug/kg b.i.d.for 12 weeks

Intervention Type: DRUG

Naltrexone 50 mg/day + Cognitive Behavioral Therapy

Naltrexone 50 mg/day for 12 weeks

Intervention Type: 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

Intervention Type: DRUG

Placebo + Cognitive Behavioral Therapy

Placebo comparator

Intervention Type: OTHER

Other Intervention Names

Zofran; Revia; Zofran and Revia; sugar pill

Eligibility 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.

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Bankole Johnson

OTHER

Sponsor Role: lead

Responsible Party

Bankole Johnson

Chair of Psychiatry and NB Sciences

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bankole Johnson, DSc,MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

UVA CARE

Charlottesville, Virginia, United States

UVA CARE Richmond

Richmond, Virginia, United States

Countries

United States

Other Identifiers

R01AA012964

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12790

Identifier Type: -

Identifier Source: org_study_id