Alcohol DependencePhase 2NCT00678457
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
A Phase 2 study testing Ondansetron and Olanzapine in people with Alcohol Dependence, run by University of Virginia at 2 sites in United States.
Trial summary
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Ondansetron and Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to May 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent
- Aged 18 years and above and weighing ≥40 kg and ≤140 kg
- Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment
- DSM-IV-R diagnosis of alcohol dependence
- Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range
- Negative pregnancy test at intake.
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- Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
- Willing to participate in behavioral treatments for alcoholism
- Answer an advertisement in the newspaper/radio/television, and express a wish to stop 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
Who cannot join
- Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol
- Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment
- Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine
- Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial
- Female subjects 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
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- Significant medical illness (including hypertension) as determined by history and/or complete physical examination.
- Gross neurological disease
- Mental retardation
- Pyrexia of unknown origin
- Diagnosis or suspicion of Alzheimer's disease
- Clinically significant abnormalities on the EKG that will preclude safe participation
- Recent (last 3 months) history of ischemic heart disease or myocardial infarction.
- Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.
- Participation in a clinical study within the last 30 days
- Elevation of liver enzymes
- History of any severe or life-threatening reaction to olanzapine or ondansetron
- Past or current history of seizures disorder
- Past or current history of diabetes
- Being treated with any medication with potential for clinically significant interactions with alcohol or olanzapine and/or ondansetron. These include:, serotonin antagonists (e.g., ritanserin or buspirone), dopamine antagonists (e.g., haloperidol), or compounds with actions similar to disulfiram (Antabuse®).
- Pending imprisonment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UVA CARE
Charlottesville, Virginia, 22911
UVA CARE Richmond
Richmond, Virginia, 23294
About this study
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.
Read the detailed description
Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.
This is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.
- Conditions
- Alcohol Dependence
- Being tested
- Ondansetron, Olanzapine, Placebo
- Keywords
- alcohol dependence, alcohol abuse, drinking, alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
ondansetron (4 μg/kg b.i.d.)
OlanzapineDrug
Also called Zyprexa
olanzapine (9, 18, and 36 μg/kg)
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| ondansetron/olanzapine | Experimental | ondansetron (4 μg/kg b.i.d.)
olanzapine (9 μg/kg) Receives: Drug: Ondansetron; Drug: Olanzapine |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics.
Measured: Throughout the study
Secondary outcomes (1)
The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2008 (estimated)
- Study startJan 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Bankole Johnson, DSc, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678457
- Sponsor's protocol ID
- TO45228
- Other IDs
- IRB-HSR #12816
- Status last verified
- Jan 2009
- First submitted
- 8 May 2008
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial
- ClinicalTrials.gov ID
- NCT00678457
- Acronym / sponsor ID
- TO45228
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, alcohol abuse, drinking, alcohol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 15 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.
Detailed description
Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.
This is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron/olanzapine | Experimental | Drug: Ondansetron, Drug: Olanzapineondansetron (4 μg/kg b.i.d.) olanzapine (9 μg/kg) |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females who have given written informed consent
- Aged 18 years and above and weighing ≥40 kg and ≤140 kg
- Drinking on average ≥21 and ≥28 drinks/week for women and men, respectively, in the 7-day period prior to enrollment
- DSM-IV-R diagnosis of alcohol dependence
- Good physical health as determined by a complete physical examination, electrocardiogram (EKG) within normal limits and laboratory screening tests within acceptable range
Key exclusion criteria (21 listed)
- Any current axis I DSM-IV psychiatric disorder other than alcohol or nicotine dependence that warrants treatment or would preclude safe participation in the protocol
- Severe alcohol withdrawal symptoms that, in the physician's opinion, require inpatient treatment
- Serious medical comorbidity requiring medical intervention or close supervision, or any condition that can interfere with the receipt of ondansetron or olanzapine
- Severe or life-threatening adverse reactions to the ondansetron or olanzapine medications in the past or during this clinical trial
- Female subjects who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: Zofranondansetron (4 μg/kg b.i.d.) | Drug | ondansetron/olanzapine |
| OlanzapineAlso: Zyprexaolanzapine (9, 18, and 36 μg/kg) | Drug | ondansetron/olanzapine |
| Placeboplacebo | Drug | placebo |
Primary outcome
The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics.
Time frame: Throughout the study
1 secondary outcome
The combination of ondansetron and olanzapine will be superior to placebo at reducing the psychosocial consequences of drinking.
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bankole Johnson, DSc, MD, PhD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ondansetron and Olanzapine in people with Alcohol Dependence, run by University of Virginia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The combination of ondansetron and olanzapine will be safe and superior to placebo at decreasing self-reported heavy drinking among early-onset alcoholics. (time frame: Throughout the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.