Alcohol Use DisorderPhase 4NCT03018704
Topiramate Treatment of Alcohol Use Disorders in African Americans
A Phase 4 study testing Topiramate in people with Alcohol Use Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-identification as African American;
- age 18 to 70 years, inclusive;
- average weekly ethanol consumption of >24 standard drinks for men or >18 standard drinks for women, with a weekly average of > 2 heavy drinking days (men: > 5 standard drinks; women: > 4 standard drinks) during the month before screening;
- a current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria);
- expressed goal to reduce or stop drinking;
- able to read English at the 6th grade or higher level and without gross cognitive impairment;
- women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment
- willing and able to provide signed, informed consent to participate in the study.
Who cannot join
- a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal;
- history of nephrolithiasis;
- history of glaucoma;
- current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, antisocial personality disorder, or imminent suicide or violence risk);
- current moderate-to-severe alcohol withdrawal requiring pharmacological treatment (see Section D.4.a. regarding alcohol detoxification);
- current DSM-IV diagnosis of drug use disorder (other than nicotine or cannabis) or a urine drug screen positive for recent use of opioids, cocaine, or amphetamines (may be repeated once and if the result is negative on repeat it is not exclusionary);
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- a history of hypersensitivity to TOP;
- current regular treatment with more than one antidepressant or any treatment with a tricyclic antidepressant;
- current treatment with a psychotropic medication (with the exception of antidepressants where monotherapy is allowable), including medications that, when combined with alcohol or TOP, present a risk of overdose or significant adverse effect (e.g., chronic opioid use) (of note we will allow subjects to discontinue medications that have no demonstrated therapeutic effect in order to enroll - amount of time off of the medication will be a clinical decision left to the discretion of the study physician investigators);
- current treatment with TOP or a medication approved for AUD;
- considered to be unsuitable candidates for receipt of an investigational drug;
- treatment with carbonic anhydrase inhibitors, due to the added risk of metabolic acidosis,
- Body Mass Index (BMI) of less than 18.5.
- untreated gout as topiramate has been shown in one study to increase uric acid.
- current treatment with dolutegravir.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
About this study
Official title: Topiramate Treatment of Alcohol Use Disorder in African Americans
The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than European Americans (EAs), AAs have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the higher rates of morbidity and mortality, pharmacological treatments are understudied in this population and there is some evidence that medications are less preferred and less effective in AAs.
Read the detailed description
- Objective(s): Despite having lower rates of drinking and heavy drinking than European Americans (EAs), African Americans (AA) have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. The current proposal aims to improve alcohol treatment in AA Veterans, who comprise 12% of the Veteran population.
- Research Design: The proposed study is a two-arm, randomized 12-week, parallel-groups comparison of topiramate versus placebo to reduce the frequency of heavy drinking days and increase the number of abstinent days in 160 AA patients with AUD.
- Methodology: The following specific aim is used to direct the methods: Specific Aim 1. Understanding health disparities. Aim 1 will focus on the screening process, using the screening outcomes data, including reasons for patients declining to participate in the trial, to conduct descriptive analyses of the screening process and recruitment efforts. We will supplement this description by examining changes in drinking and motivation for treatment before and during the pandemic. In the resultant manuscript, we will also discuss strategies for recruiting a minority population to participate in addiction treatment studies. Specific Aim 2. Future study planning with safety results. Aim 2 will focus on assessing the safety and tolerability of topiramate dosing, which will provide the basis for evaluating the risks associated with topiramate treatment for reducing heavy drinking in AAs. The additional participants will greatly improve our effect size estimate, pooling across sites; for example, the width of a confidence interval on a difference in means at the end of the study based on a sample of size 80 will be 61% of the width of a corresponding confidence interval based on a sample of size 30. In addition, two sites will also provide information on treatment-by-site heterogeneity, which will be useful for informing the design of a multi-site trial, which we believe is the best option for recruiting an adequate sample for a well powered efficacy trial. To increase the number of subjects exposed to topiramate treatment, we will randomize participants to a 2:1 ratio of topiramate to placebo treatment. Specific Aim 3. Combined analysis with available RCT datasets. We have data available from two completed RCTs of topiramate that used a design almost identical to that of the present study (n's = 138 and 170, including 16 AAs). We plan to conduct an analysis that combines the data from the three trials, to test for differences in efficacy by population group (i.e., AAs and EAs), and to compare adverse event profiles across population groups. Combining the datasets will allow analyses that incorporate individual-level heterogeneity, in contrast to meta-analyses, where typically only group comparisons would be possible. This will be accomplished using de-identified data from each study.
- Impact/Significance: The proposal is innovative in that it will focus on AAs with AUD, an understudied and underserved population for whom no such data currently exist. Given the far-reaching effects of AUD and its high prevalence among Veterans, added evidence based treatments may realize reduced health care costs from unnecessary ED visits and reduced complications of illnesses such as hepatitis C and congestive heart failure.
- Conditions
- Alcohol Use Disorder
- Being tested
- Topiramate, placebo
- Keywords
- alcoholism, treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
anticonvulsant medication. The medication was dosed twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable.
placeboDrug
inactive medication. the doses of placebo were titrated the same as the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | a placebo control arm Receives: Drug: placebo |
| Topiramate | Experimental | Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients. The medication was dosed orally twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable. Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Days of Heavy Drinking
Drinking was recorded using the timeline follow back methodology which is an interview based method to record drinking on each day during the trial. The summary measure (% days heavy drinking) counts the number of days of heavy drinking (>4drinks per day) divided by the number of observation days to report the percent of observation days for which there is heavy drinking. For the the outcome measure the observation period is the last 42 days of the trial.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start1 Aug 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: In ability to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David W. Oslin, MD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018704
- Sponsor's protocol ID
- NURA-010-16S
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2017
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Treatment of Alcohol Use Disorder in African Americans
- ClinicalTrials.gov ID
- NCT03018704
- Acronym / sponsor ID
- NURA-010-16S
- Conditions
- Alcohol Use Disorder
- Keywords
- alcoholism, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In ability to recruit
- Enrolment
- 79 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The focus of this application is on the improvement of services for African American (AAs) Veterans afflicted with an alcohol use disorder. The project focuses on the use of topiramate as a treatment for alcohol use disorders. Despite having lower rates of heavy drinking than European Americans (EAs), AAs have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. Despite the higher rates of morbidity and mortality, pharmacological treatments are understudied in this population and there is some evidence that medications are less preferred and less effective in AAs.
Detailed description
- Objective(s): Despite having lower rates of drinking and heavy drinking than European Americans (EAs), African Americans (AA) have significantly higher rates of mortality from a variety of alcohol-related conditions, including liver cirrhosis, accidents, and violence. The current proposal aims to improve alcohol treatment in AA Veterans, who comprise 12% of the Veteran population.
- Research Design: The proposed study is a two-arm, randomized 12-week, parallel-groups comparison of topiramate versus placebo to reduce the frequency of heavy drinking days and increase the number of abstinent days in 160 AA patients with AUD.
- Methodology: The following specific aim is used to direct the methods: Specific Aim 1. Understanding health disparities. Aim 1 will focus on the screening process, using the screening outcomes data, including reasons for patients declining to participate in the trial, to conduct descriptive analyses of the screening process and recruitment efforts. We will supplement this description by examining changes in drinking and motivation for treatment before and during the pandemic. In the resultant manuscript, we will also discuss strategies for recruiting a minority population to participate in addiction treatment studies. Specific Aim 2. Future study planning with safety results. Aim 2 will focus on assessing the safety and tolerability of topiramate dosing, which will provide the basis for evaluating the risks associated with topiramate treatment for reducing heavy drinking in AAs. The additional participants will greatly improve our effect size estimate, pooling across sites; for example, the width of a confidence interval on a difference in means at the end of the study based on a sample of size 80 will be 61% of the width of a corresponding confidence interval based on a sample of size 30. In addition, two sites will also provide information on treatment-by-site heterogeneity, which will be useful for informing the design of a multi-site trial, which we believe is the best option for recruiting an adequate sample for a well powered efficacy trial. To increase the number of subjects exposed to topiramate treatment, we will randomize participants to a 2:1 ratio of topiramate to placebo treatment. Specific Aim 3. Combined analysis with available RCT datasets. We have data available from two completed RCTs of topiramate that used a design almost identical to that of the present study (n's = 138 and 170, including 16 AAs). We plan to conduct an analysis that combines the data from the three trials, to test for differences in efficacy by population group (i.e., AAs and EAs), and to compare adverse event profiles across population groups. Combining the datasets will allow analyses that incorporate individual-level heterogeneity, in contrast to meta-analyses, where typically only group comparisons would be possible. This will be accomplished using de-identified data from each study.
- Impact/Significance: The proposal is innovative in that it will focus on AAs with AUD, an understudied and underserved population for whom no such data currently exist. Given the far-reaching effects of AUD and its high prevalence among Veterans, added evidence based treatments may realize reduced health care costs from unnecessary ED visits and reduced complications of illnesses such as hepatitis C and congestive heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboa placebo control arm |
| Topiramate | Experimental | Drug: TopiramateTopiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients. The medication was dosed orally twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- self-identification as African American;
- age 18 to 70 years, inclusive;
- average weekly ethanol consumption of >24 standard drinks for men or >18 standard drinks for women, with a weekly average of > 2 heavy drinking days (men: > 5 standard drinks; women: > 4 standard drinks) during the month before screening;
- a current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria);
- expressed goal to reduce or stop drinking;
Key exclusion criteria (15 listed)
- a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal;
- history of nephrolithiasis;
- history of glaucoma;
- current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, antisocial personality disorder, or imminent suicide or violence risk);
- current moderate-to-severe alcohol withdrawal requiring pharmacological treatment (see Section D.4.a. regarding alcohol detoxification);
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 |
|---|---|---|
| TopiramateAlso: Topamaxanticonvulsant medication. The medication was dosed twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable. | Drug | Topiramate |
| placeboinactive medication. the doses of placebo were titrated the same as the active intervention. | Drug | Placebo |
Primary outcome
Percent Days of Heavy Drinking
Time frame: 12 weeks
Drinking was recorded using the timeline follow back methodology which is an interview based method to record drinking on each day during the trial. The summary measure (% days heavy drinking) counts the number of days of heavy drinking (>4drinks per day) divided by the number of observation days to report the percent of observation days for which there is heavy drinking. For the the outcome measure the observation period is the last 42 days of the trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
David W. Oslin, MD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topiramate in people with Alcohol Use Disorder, run by VA Office of Research and Development 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 8 inclusion and 15 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 23 Mar 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Days of Heavy Drinking (time frame: 12 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 23 Mar 2023.