Alcohol DependencePhase 2NCT00300742
Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individuals
A Phase 2 study testing Topiramate in people with Alcohol Dependence and Binge Eating, run by University of Virginia at 2 sites in United States.
Trial summary
The purpose of this study is to test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Binge Eating
- What is being tested?
- Topiramate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Jul 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females that have given written informed consent.
- Good physical health as confirmed by a complete physical examination, vital signs including an EKG within normal limits, laboratory screening tests within acceptable parameters (see exclusion criteria), as well as a baseline psychiatric history
- Diagnosis of alcohol dependence and binge eating disorder.
- Subjects must have 3 or more binge days per week in the 2-week period prior to Screen.
- Subjects may have uncomplicated and well-controlled Type II diabetes and/or hypertension that has been well controlled by diet and/or oral agent therapy for at least 3 months prior to screen.
- Provide evidence of stable residence in the last month.
Show all 9Show fewer
- The pregnancy test for females at intake must be negative. The female patients must either be sterile, post menopausal, or practicing an acceptable form of contraception.
- Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatment.
- Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- Any current DSM-IV psychiatric diagnosis other than alcohol, nicotine dependence or binge eating disorder
- Subjects who have begun to receive formal psychotherapy (cognitive-behavioral therapy, interpersonal therapy, dietary behavioral therapy*, or self-guided cognitive-behavioral) for binge-eating disorder or any other psychiatric disorder within 30 days prior to Screen. Subjects who have been engaged in formal psychotherapy for a longer period of time and plan to maintain therapy will be judged on a case-by-case basis.
- Formal dietary behavioral therapy applies to therapy where the subject is diagnosed with an eating disorder and/or the health case provider is billing for costs of therapy (will be considered on a case-by-case basis if started within 30 days of Screen. Subjects engaged in dietary for obesity only (e.g., Jenny Craig, Weight Watchers, Overeater's Anonymous) should discontinue therapy prior to study entry (no washout applies).
- Clinically significant laboratory screening test.
- Clinically significant cardiovascular disease on a 12 lead EKG.
- Symptomatic coronary artery disease or peripheral vascular disease.
Show all 15Show fewer
- Malignancy or history of malignancy within the past 5 years (except basal cell carcinoma).
- Clinically significant neurological disease.
- Clinically significant renal disease or impaired renal function as defined by subjects with an estimated creatinine clearance of less than 60 mL/min.
- Severe withdrawal symptoms which in the physicians' opinion requires inpatient treatment or severe or life-threatening adverse reactions to medications either in the past or during this clinical trial.
- Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
- Members of the same household.
- History of severe hypersensitivity to any medication or environmental allergens.
- Subjects with prior non-response to topiramate for the treatment of binge-eating and or alcohol disorder following an adequate trial of this medication
- Subjects who have been previously treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate.
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
Official title: Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individual
The purpose of this study is to test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder.
Read the detailed description
Research has shown an alarming coincidence of binge eaters also reporting serious alcohol abuse. Evidence has shown this population to have higher rates of psychiatric comorbidity, higher caloric intakes during meals, higher rates of tobacco use, more frequent binge episodes, and an earlier age of onset for binge eating and alcohol abuse. It is believed that topiramate may reduce binge eating and has been found helpful in reducing the cravings associated with alcohol consumption.
This study is to test the feasibility of administering topiramate to individuals with alcohol dependence and binge eating disorder. This will involve determining the adequacy of the amount of assessment and scheduled visits.
- Conditions
- Alcohol Dependence, Binge Eating
- Being tested
- Topiramate
- Keywords
- drinking, eating, obesity, alcohol, binge eating
- Medical subject headings
- Alcoholism, Bulimia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Topiramate up to 300 mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Drug: Topiramate Other Name for Topiramate: Topamax Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance With Study Requirements: Attendance at Treatment Sessions
Measured: up to 12 weeks
Mean Drinks Per Day at Baseline vs. Visit 12
Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Measured: up to 24 weeks
Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12
Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Measured: up to 24 weeks
Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12
Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Measured: up to 24 weeks
Compliance With Study Requirements: Topiramate Level
Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionJul 2008
- Study completionJul 2008
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nassima Ait-Daoud Tiouririne, University of Virginia
- Investigators
- Nassima Ait-Daoud, MD, Principal investigator, University of Virginia, Department of Psychiatric Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300742
- Sponsor's protocol ID
- 12069
- Status last verified
- Feb 2012
- First submitted
- 7 Mar 2006
- Last updated
- 12 Jul 2017
- 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 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate for the Treatment of Alcohol Dependent Binge-Eating Disordered Individual
- ClinicalTrials.gov ID
- NCT00300742
- Acronym / sponsor ID
- 12069
- Conditions
- Alcohol Dependence, Binge Eating
- Keywords
- drinking, eating, obesity, alcohol, binge eating
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 9 Mar 2006 (estimated)
- Results
- Posted 11 May 2017
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 test the feasibility of using topiramate to reduce binge eating and drinking episodes in alcohol dependent individuals with comorbid binge eating disorder.
Detailed description
Research has shown an alarming coincidence of binge eaters also reporting serious alcohol abuse. Evidence has shown this population to have higher rates of psychiatric comorbidity, higher caloric intakes during meals, higher rates of tobacco use, more frequent binge episodes, and an earlier age of onset for binge eating and alcohol abuse. It is believed that topiramate may reduce binge eating and has been found helpful in reducing the cravings associated with alcohol consumption.
This study is to test the feasibility of administering topiramate to individuals with alcohol dependence and binge eating disorder. This will involve determining the adequacy of the amount of assessment and scheduled visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: TopiramateDrug: Topiramate Other Name for Topiramate: Topamax |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females that have given written informed consent.
- Good physical health as confirmed by a complete physical examination, vital signs including an EKG within normal limits, laboratory screening tests within acceptable parameters (see exclusion criteria), as well as a baseline psychiatric history
- Diagnosis of alcohol dependence and binge eating disorder.
- Subjects must have 3 or more binge days per week in the 2-week period prior to Screen.
- Subjects may have uncomplicated and well-controlled Type II diabetes and/or hypertension that has been well controlled by diet and/or oral agent therapy for at least 3 months prior to screen.
Key exclusion criteria (15 listed)
- Any current DSM-IV psychiatric diagnosis other than alcohol, nicotine dependence or binge eating disorder
- Subjects who have begun to receive formal psychotherapy (cognitive-behavioral therapy, interpersonal therapy, dietary behavioral therapy*, or self-guided cognitive-behavioral) for binge-eating disorder or any other psychiatric disorder within 30 days prior to Screen. Subjects who have been engaged in formal psychotherapy for a longer period of time and plan to maintain therapy will be judged on a case-by-case basis.
- Clinically significant laboratory screening test.
- Clinically significant cardiovascular disease on a 12 lead EKG.
- Symptomatic coronary artery disease or peripheral vascular disease.
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: TopamaxTopiramate up to 300 mg per day. | Drug | Topiramate |
Primary outcome
Compliance With Study Requirements: Attendance at Treatment Sessions
Time frame: up to 12 weeks
Mean Drinks Per Day at Baseline vs. Visit 12
Time frame: up to 24 weeks
Mean drinks per day at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Mean Percent Days Abstinent Per Week at Baseline vs. Visit 12
Time frame: up to 24 weeks
Mean percent days abstinent per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Mean Binge Eating Episodes Per Week at Baseline vs. Visit 12
Time frame: up to 24 weeks
Mean binge eating episodes per week at baseline vs. Visit 12 measured by self report on timeline follow-back (TLFB) calendars in conjunction with the subject's daily diary
Compliance With Study Requirements: Topiramate Level
Time frame: up to 12 weeks
Number of subjects who escalated to the maximum dose of 300 mg of topiramate/day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alcohol Dependence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
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.
Nassima Ait-Daoud, MD principal investigator
University of Virginia, Department of Psychiatric Medicine
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 Topiramate in people with Alcohol Dependence and Binge Eating, 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 9 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: finished, as of the sponsor's last update on 12 Jul 2017. 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. 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?
Yes. Results are posted in the registry (first posted 11 May 2017). 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?
Compliance With Study Requirements: Attendance at Treatment Sessions (time frame: up to 12 weeks). The study lists 5 primary outcomes in all. 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 12 Jul 2017.