Combined Pharmacotherapies for Alcoholism
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Placebo + Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring Alcohol, Alcohol Dependence, Alcoholism
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.
- 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
Sites / Locations
- UVA CARE
- UVA CARE Richmond
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Ondansetron
Naltrexone
Ondansetron + Naltrexone
Placebo
Arm Description
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Placebo + Cognitive Behavioral Therapy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00768508
First Posted
October 6, 2008
Last Updated
March 14, 2013
Sponsor
Bankole Johnson
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00768508
Brief Title
Combined Pharmacotherapies for Alcoholism
Official Title
Combined Pharmacotherapies for Alcoholism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bankole Johnson
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol, Alcohol Dependence, Alcoholism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Arm Title
Naltrexone
Arm Type
Experimental
Arm Description
Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Arm Title
Ondansetron + Naltrexone
Arm Type
Experimental
Arm Description
Ondansetron 4 ug/kg b.i.d. + Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + Cognitive Behavioral Therapy
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4 ug/kg b.i.d. + Cognitive Behavioral Therapy
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron 4 ug/kg b.i.d.for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Other Intervention Name(s)
Revia
Intervention Description
Naltrexone 50 mg/day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Ondansetron 4 ug/kg b.i.d.+ Naltrexone 50 mg/day + Cognitive Behavioral Therapy
Other Intervention Name(s)
Zofran and Revia
Intervention Description
Combination of ondansetron 4 ug/kg b.i.d. and naltrexone 50 mg/day for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo + Cognitive Behavioral Therapy
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Description
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
Time Frame
Throughout the study
Secondary Outcome Measure Information:
Title
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Description
Pill Count, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM
Time Frame
Throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bankole Johnson, DSc,MD,PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA CARE
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
UVA CARE Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
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Combined Pharmacotherapies for Alcoholism
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