Combined Pharmacotherapies for Alcoholism

Alcoholism Clinical Trial

Official title:

Combined Pharmacotherapies for Alcoholism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00768508
• Other study ID #: 12790
• Secondary ID: R01AA012964
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2008
• Last updated: March 14, 2013
• Start date: September 2008
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Ondansetron 4 ug/kg b.i.d.for 12 weeks
• Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Naltrexone 50 mg/day for 12 weeks
• 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:
• Placebo + Cognitive Behavioral Therapy
Placebo comparator

Locations

Country	Name	City	State
United States	UVA CARE	Charlottesville	Virginia
United States	UVA CARE Richmond	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Bankole Johnson	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption	Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT	Throughout the study	No
Secondary	Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors	Pill Count, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM	Throughout the study	Yes