AlcoholismPhase 2/3NCT01591291
Pharmacogenetic Treatments for Alcoholism
A Phase 2/3 study testing Ondansetron + Brief Behavioral Enhancement Treatment in people with Alcoholism, run by University of Virginia at 2 sites in United States.
Trial summary
Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Ondansetron + Brief Behavioral Enhancement Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Feb 2018
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who have given written informed consent
- Between the ages of 18 and 65 years and weighing within 30% of ideal body weight. Also, patients must weigh at least 40 kg and no more than 155 kg.
- Good physical health as determined by a complete physical examination, an electrocardiogram (EKG) within normal limits, and laboratory screening tests within acceptable parameters.
- Current DSM-IV diagnosis of alcohol dependence
- AUDIT score of ≥8
- Currently drinking ≥14 alcohol units/week for women and ≥21 alcohol units/week for men in the last 30 days, and have met this criteria prior to randomization
Show all 10Show fewer
- Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next 9 months.
- 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
- Expressed a wish to reduce or stop drinking
- Willingness to participate in behavioral treatments for alcoholism
Who cannot join
- Please contact site for additional information
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, 22911
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, 23294
About this study
Official title: 1/2 - Pharmacogenetic Treatments for Alcoholism
Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. A novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication.
This study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of DNA, the material that controls the inheritance of characteristics). The proposed study will address a number of limitations in the prior work, including testing the medication in both European-American and African-American samples.
Read the detailed description
This study is a 24 week clinical trial. During the 24 weeks participants will receive either ondansetron or placebo. Participants will also receive Brief Behavioral Compliance enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e., African-Americans and European-Americans), each with 128 treatment-seeking, alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs. TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group assignment will be achieved using a block randomization procedure that balances the treatment groups on PHDD, age, and gender.
- Conditions
- Alcoholism
- Being tested
- Ondansetron + Brief Behavioral Enhancement Treatment, Placebo + Brief Behavioral Enhancement Treatment
- Keywords
- alcohol dependence, alcohol addiction
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron + Brief Behavioral Enhancement TreatmentDrug
Also called Zofran
Ondansetron 4ug/kg twice daily
Placebo + Brief Behavioral Enhancement TreatmentDrug
Also called Sugar Pill
Placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Not described Receives: Drug: Ondansetron + Brief Behavioral Enhancement Treatment |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo + Brief Behavioral Enhancement Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent heavy drinking days
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.
Measured: up to 24 weeks
Secondary outcomes (5)
Drinks per drinking day
From the TLFB data, other measures of drinking such as drinking intensity (drinks per drinking day; DDD) will be derived.
Measured: up to 24 weeks
Percentage of days abstinent
From the TLFB data, other measures of drinking such as the percentage of days abstinent (PDA) will be derived.
Measured: up to 24 weeks
Percentage of subjects with no heavy drinking days
The TLFB will also be used for other experimental measures that we have validated in previous studies, such as the percentage of subjects with no heavy drinking.
Measured: up to 24 weeks
Measures of quality of life
Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire and Short Index of Problems.
Measured: Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
Objective measure of treatment measure and adverse event using RNA
We will collect RNA samples and using genome-wide expression studies of total RNA, we will compare 15 of the most responsive and 15 of the most least responsive on percent heavy drinking days and 15 with the most and 15 with the fewest adverse events, we will identify changes that mediate ondansetron's efficacy and adverse event profile, respestively.
Measured: We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: Grant was transferred to University of Maryland and results were reported under NCT02354703.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Bankole Johnson, DSc, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591291
- Sponsor's protocol ID
- G15991
- Status last verified
- Apr 2023
- First submitted
- 17 Apr 2012
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1/2 - Pharmacogenetic Treatments for Alcoholism
- ClinicalTrials.gov ID
- NCT01591291
- Acronym / sponsor ID
- G15991
- Conditions
- Alcoholism
- Keywords
- alcohol dependence, alcohol addiction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant was transferred to University of Maryland and results were reported under NCT02354703.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jun 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 3 May 2012 (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.
Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. A novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication.
This study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of DNA, the material that controls the inheritance of characteristics). The proposed study will address a number of limitations in the prior work, including testing the medication in both European-American and African-American samples.
Detailed description
This study is a 24 week clinical trial. During the 24 weeks participants will receive either ondansetron or placebo. Participants will also receive Brief Behavioral Compliance enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e., African-Americans and European-Americans), each with 128 treatment-seeking, alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs. TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group assignment will be achieved using a block randomization procedure that balances the treatment groups on PHDD, age, and gender.
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 | Experimental | Drug: Ondansetron + Brief Behavioral Enhancement Treatment |
| Placebo | Placebo comparator | Drug: Placebo + Brief Behavioral Enhancement Treatment |
Who may qualify
- Ages
- 18 to 65 years
- 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
- Between the ages of 18 and 65 years and weighing within 30% of ideal body weight. Also, patients must weigh at least 40 kg and no more than 155 kg.
- Good physical health as determined by a complete physical examination, an electrocardiogram (EKG) within normal limits, and laboratory screening tests within acceptable parameters.
- Current DSM-IV diagnosis of alcohol dependence
- AUDIT score of ≥8
Key exclusion criteria (1 listed)
- Please contact site for additional information
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 |
|---|---|---|
| Ondansetron + Brief Behavioral Enhancement TreatmentAlso: ZofranOndansetron 4ug/kg twice daily | Drug | Ondansetron |
| Placebo + Brief Behavioral Enhancement TreatmentAlso: Sugar PillPlacebo twice daily | Drug | Placebo |
Primary outcome
Percent heavy drinking days
Time frame: up to 24 weeks
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.
5 secondary outcomes
Drinks per drinking day
Time frame: up to 24 weeks
Percentage of days abstinent
Time frame: up to 24 weeks
Percentage of subjects with no heavy drinking days
Time frame: up to 24 weeks
Measures of quality of life
Time frame: Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24)
Objective measure of treatment measure and adverse event using RNA
Time frame: We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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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 2/3 study testing Ondansetron + Brief Behavioral Enhancement Treatment in people with Alcoholism, 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 1 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: withdrawn, as of the sponsor's last update on 20 Apr 2023. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Percent heavy drinking days (time frame: up to 24 weeks). 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 20 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.