Alcohol AbusePhase 2NCT00890149
Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
A Phase 2 study testing Ondansetron and BASICS Plus in people with Alcohol Abuse and Alcoholism, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention for College Students) has been the most validated brief intervention among college students. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Abuse, Alcoholism
- What is being tested?
- Ondansetron and BASICS Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Mar 2017
- 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 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- White Males and females who have given written informed consent.
- Ages 18 through 25;also, patients must weigh ≥40 kg and ≤140 kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
- At least an average of one episode of binge or heavy drinking per week in the past month prior to enrollment. For men and women, that is ≥5 and ≥4 drinks/drinking day, respectively.They also need to report at least one day of heavy drinking within the 7 days prior to randomization.
- The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception.
- 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.
- Answer an advertisement in the newspaper/radio/television, and express a wish to stop heavy drinking.
- Willingness to participate in behavioral treatments to stop heavy drinking
Who cannot join
- Please contact site for additional information
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Neurobehavioral Center
Columbia, Maryland, 21045
About this study
This study will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention for College Students) has been the most validated brief intervention among college students. The BASICS program provides personal feedback, motivation, and strategies that enhance normative drinking patterns
Read the detailed description
We propose to conduct a 9 week study to test the efficacy of ondansetron in a heavy drinking (non-dependent) emerging adult population. We will enroll individuals between the ages of 18 and 25 years as this period overlaps with the general population of those attending college and who can be defined as emerging adults. We will conduct a double-blind control study in which 150 individuals will be randomized into 2 groups, therefore the N will be 300.
- Conditions
- Alcohol Abuse, Alcoholism
- Being tested
- Ondansetron, Placebo, BASICS Plus
- Keywords
- alcohol abuse, binge drinking, severe drinking, alcoholism, heavy drinking
- Medical subject headings
- Alcoholism, Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Ondansetron (4ug/kg bid),
PlaceboDrug
Also called Sugar pill
Placebo bid
BASICS PlusBehavioural
Brief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron + BASICS Plus Receives: Drug: Ondansetron; Behavioral: BASICS Plus |
| Placebo | Placebo comparator | Placebo + BASICS Plus Receives: Drug: Placebo; Behavioral: BASICS Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ondansetron + BASICS Plus shall be more effective at reducing severe or binge drinking among emerging adults. The treatment effect of ondansetron on reduction in severe or binge drinking shall be greatest in LL individuals.
Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping
Measured: Throughout the study
Secondary outcomes (1)
Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change
ICR Scale to abstain from using alcohol, ICR Scale for medication adherence, medication compliance,craving assessments
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 posted29 Apr 2009 (estimated)
- Study startSep 2015
- Primary completionSep 2016
- Study completionMar 2017
Why it stopped: Difficulty recruiting target sample
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- 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 Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890149
- Sponsor's protocol ID
- HP-00063000
- Other IDs
- 2R01AA010522-13
- Status last verified
- May 2023
- First submitted
- 27 Apr 2009
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: A IPD sharing plan has not been developed.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults
- ClinicalTrials.gov ID
- NCT00890149
- Acronym / sponsor ID
- HP-00063000
- Conditions
- Alcohol Abuse, Alcoholism
- Keywords
- alcohol abuse, binge drinking, severe drinking, alcoholism, heavy drinking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting target sample
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 29 Apr 2009 (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 will evaluate the efficacy of ondansetron + BASICS Plus in reducing severe or binge drinking among emerging adults. BASIC Plus (Brief Alcohol Screening and Intervention for College Students) has been the most validated brief intervention among college students. The BASICS program provides personal feedback, motivation, and strategies that enhance normative drinking patterns
Detailed description
We propose to conduct a 9 week study to test the efficacy of ondansetron in a heavy drinking (non-dependent) emerging adult population. We will enroll individuals between the ages of 18 and 25 years as this period overlaps with the general population of those attending college and who can be defined as emerging adults. We will conduct a double-blind control study in which 150 individuals will be randomized into 2 groups, therefore the N will be 300.
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, Behavioral: BASICS PlusOndansetron + BASICS Plus |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: BASICS PlusPlacebo + BASICS Plus |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- White Males and females who have given written informed consent.
- Ages 18 through 25;also, patients must weigh ≥40 kg and ≤140 kg.
- Good physical health as determined by a complete physical examination, an EKG within normal limits, and laboratory screening tests within acceptable parameters.
- At least an average of one episode of binge or heavy drinking per week in the past month prior to enrollment. For men and women, that is ≥5 and ≥4 drinks/drinking day, respectively.They also need to report at least one day of heavy drinking within the 7 days prior to randomization.
- The pregnancy test for females at intake must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception.
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 |
|---|---|---|
| OndansetronAlso: ZofranOndansetron (4ug/kg bid), | Drug | Ondansetron |
| PlaceboAlso: Sugar pillPlacebo bid | Drug | Placebo |
| BASICS PlusBrief Alcohol Screening and Intervention for College Students. Brief behavioral intervention to reduce drinking. | Behavioural | Ondansetron, Placebo |
Primary outcome
Ondansetron + BASICS Plus shall be more effective at reducing severe or binge drinking among emerging adults. The treatment effect of ondansetron on reduction in severe or binge drinking shall be greatest in LL individuals.
Time frame: Throughout the study
Self-report use, Timeline Follow-back, daily drinking questionnaires, Rutgers Alcohol Problem Index, Genotyping
1 secondary outcome
Ondansetron adds to the therapeutic benefit of BASICS Plus, even in those with lower readiness for change
Time frame: Throughout the study
Results and safety
The study was stopped early (reason given: Difficulty recruiting target sample). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- Individual participant dataSharing planned: Undecided. A IPD sharing plan has not been developed.
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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 Maryland, Baltimore
1 site 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 BASICS Plus in people with Alcohol Abuse and Alcoholism, run by University of Maryland, Baltimore at 1 site 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 8 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: stopped early, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Difficulty recruiting target sample). Results are not available in the source record.
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?
Ondansetron + BASICS Plus shall be more effective at reducing severe or binge drinking among emerging adults. The treatment effect of ondansetron on reduction in severe or binge drinking shall be greatest in LL individuals. (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 26 May 2023.