AlcoholismPhase 2NCT00006205
Alcohol Dependency Study: Combining Medication Treatment for Alcoholism
A Phase 2 study testing ondansetron + cognitive behavioral therapy, topiramate + cognitive behavioral therapy and ondansetron + topiramate + cognitive behavioral therapy in people with Alcoholism, run by Bankole Johnson at 2 sites in United States.
Trial summary
The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- ondansetron + cognitive behavioral therapy, topiramate + cognitive behavioral therapy and ondansetron + topiramate + cognitive behavioral therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Dec 2013
- 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
- Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
- Provide a written, informed consent.
- Good physical health and must weigh within at least 40 kg and no more than 140 kg.
- Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
- Willingness to participate in behavioral treatments for alcoholism.
- Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.
Who cannot join
- Please contact site for additional information
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, 22911
Mindy Borszich, 888-882-2345, mcb3x@virginia.edu
Eva Jenkins-Mendoza, (434)243-0562, emj9c@virginia.edu
- Recruiting
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, 23294
Mindy Borszich, 888-882-2345, mcb3x@virginia.edu
Eva Jenkins-Mendoza, (434)243-0562, emj9c@virginia.edu
About this study
Official title: Combining Medications Treatment for Alcoholism
The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
Read the detailed description
This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.
- Conditions
- Alcoholism
- Being tested
- ondansetron + cognitive behavioral therapy, topiramate + cognitive behavioral therapy, Placebo + cognitive behavioral therapy, ondansetron + topiramate + cognitive behavioral therapy
- Keywords
- alcoholism, 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 + cognitive behavioral therapyDrug
Also called Zofran
ondansetron (4 mcg/kg b.i.d)
topiramate + cognitive behavioral therapyDrug
Also called Topamax
topiramate (up to 300 mg/day)
Placebo + cognitive behavioral therapyDrug
Also called sugar pill
placebo
ondansetron + topiramate + cognitive behavioral therapyDrug
Also called zofran, topamax
ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron + cognitive behavioral therapy Receives: Drug: ondansetron + cognitive behavioral therapy |
| Topiramate | Experimental | Topiramate + cognitive behavioral therapy Receives: Drug: topiramate + cognitive behavioral therapy |
| Placebo | Placebo comparator | Placebo + cognitive behavioral therapy Receives: Drug: Placebo + cognitive behavioral therapy |
| Ondansetron + Topiramate | Experimental | Ondansetron + Topiramate + cognitive behavioral therapy Receives: Drug: ondansetron + topiramate + cognitive behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the study
Secondary outcomes (1)
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Pill Count, Q-LES-Q, SFQ, AASE, ADBS, OCDS, CIWA-Ar, CGI, TCI, MAC, AOQ, FHAM
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 posted12 Sep 2000 (estimated)
- Study startMar 2005
- Primary completionJun 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bankole Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Bankole Johnson, University of Virginia
- Investigators
- Bankole Johnson, DSc, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006205
- Sponsor's protocol ID
- NIAAAJOH1052207A1
- Other IDs
- R01AA013964
- Status last verified
- Mar 2013
- First submitted
- 11 Sep 2000
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. doi: 10.1517/14656566.5.9.1943.
PubMed 15330732
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Medications Treatment for Alcoholism
- ClinicalTrials.gov ID
- NCT00006205
- Acronym / sponsor ID
- NIAAAJOH1052207A1
- Conditions
- Alcoholism
- Keywords
- alcoholism, alcohol addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Bankole JohnsonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Mar 2005
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Sep 2000 (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.
The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.
Detailed description
This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: ondansetron + cognitive behavioral therapyOndansetron + cognitive behavioral therapy |
| Topiramate | Experimental | Drug: topiramate + cognitive behavioral therapyTopiramate + cognitive behavioral therapy |
| Placebo | Placebo comparator | Drug: Placebo + cognitive behavioral therapyPlacebo + cognitive behavioral therapy |
| Ondansetron + Topiramate | Experimental | Drug: ondansetron + topiramate + cognitive behavioral therapyOndansetron + Topiramate + cognitive behavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
- Provide a written, informed consent.
- Good physical health and must weigh within at least 40 kg and no more than 140 kg.
- Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
- Willingness to participate in behavioral treatments for alcoholism.
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 + cognitive behavioral therapyAlso: Zofranondansetron (4 mcg/kg b.i.d) | Drug | Ondansetron |
| topiramate + cognitive behavioral therapyAlso: Topamaxtopiramate (up to 300 mg/day) | Drug | Topiramate |
| Placebo + cognitive behavioral therapyAlso: sugar pillplacebo | Drug | Placebo |
| ondansetron + topiramate + cognitive behavioral therapyAlso: zofran, topamaxondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day) | Drug | Ondansetron + Topiramate |
Primary outcome
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption
Time frame: Throughout the study
Drinks per drinking day, Drinks per day, Percent Days Abstinent, BAC, CDT, GGT
1 secondary outcome
Medication compliance, alcohol craving, social functioning, quality of life, alcohol withdrawal, attendance at psychosocial services, pre-morbid risk factors
Time frame: Throughout the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Background: PubMed 15330732Johnson BA. An overview of the development of medications including novel anticonvulsants for the treatment of alcohol dependence. Expert Opin Pharmacother. 2004 Sep;5(9):1943-55. doi: 10.1517/14656566.5.9.1943.
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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 + cognitive behavioral therapy, topiramate + cognitive behavioral therapy and ondansetron + topiramate + cognitive behavioral therapy in people with Alcoholism, run by Bankole Johnson 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 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mindy Borszich (1-888-882-2345, mcb3x@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report measures of alcohol-related problems and consumption, Objective measures of alcohol consumption (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?
On the ClinicalTrials.gov record for NCT00006205, which also lists 1 linked publication.
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 15 Mar 2013.