Alcohol DependencePhase 2/3ETHoPA-RNCT01145677
Efficacy of Topiramate for Hospitalized Patients With Alcoholism
A Phase 2/3 study testing Topiramate in people with Alcohol Dependence, run by Chiang Mai University at 4 sites in Thailand.
Trial summary
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesThailand
- Study dates
- Jun 2010to Jun 2011
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients hospitalized due to alcohol-related problem
- DSM-IV-TR alcohol dependence
- for male: history of alcohol drink >=35/week, female: history of alcohol drink >=28/week for at least 1 week during four weeks prior to the admission
- AUDIT score at least 8
- mild or no alcohol withdrawal symptom
- BMI > 18 kg/m2
- not pregnant and no plan for pregnancy
- intention to decrease or stop drinking
Who cannot join
- severe psychiatric and cognitive disorders
- other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
- taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- unstable medical condition
- medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
- moderate to high risk of suicide
Show all 10Show fewer
- under legal process
- plan to receive a formal treatment for alcoholism from other treatment settings
- pregnancy and nursing woman
- abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
Chiang Mai Drug Dependence Treatment Center
Maerim, Chiang Mai, 50180
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200
Suanprung Psychiatric Hospital
Muang, ChiangMai, 50100
Maharaj Nakorn Chiang Mai Hospital
Muang, ChiangMai, 50200
About this study
Official title: Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
- Conditions
- Alcohol Dependence
- Being tested
- Topiramate
- Keywords
- Alcohol dependence, Alcoholism, Topiramate
- 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
Topiramate 100-300 mg/day orally twice per day
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Not described Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol drink/day
Alcohol drink/day assessed by the use of time line follow back
Measured: 12 weeks
Secondary outcomes (1)
Common adverse effect
Common adverse effect will be assessed by the use of questionaire and self-report
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Investigators
- Surinporn Likhitsathian, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145677
- Sponsor's protocol ID
- THoPA-R
- Acronym
- ETHoPA-R
- Status last verified
- Jun 2010
- First submitted
- 16 Jun 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT01145677
- Acronym / sponsor ID
- ETHoPA-R / THoPA-R
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, Alcoholism, Topiramate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jun 2010 (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 is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: Topiramate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- patients hospitalized due to alcohol-related problem
- DSM-IV-TR alcohol dependence
- for male: history of alcohol drink >=35/week, female: history of alcohol drink >=28/week for at least 1 week during four weeks prior to the admission
- AUDIT score at least 8
- mild or no alcohol withdrawal symptom
Key exclusion criteria (10 listed)
- severe psychiatric and cognitive disorders
- other substance dependence, except nicotine and caffeine dependence, during 6 months prior to enrollment
- taking antipsychotics, mood stabilizers, anticonvulsants, opioid analgesics, systemic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- unstable medical condition
- medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
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 100-300 mg/day orally twice per day | Drug | Topiramate |
Primary outcome
Alcohol drink/day
Time frame: 12 weeks
Alcohol drink/day assessed by the use of time line follow back
1 secondary outcome
Common adverse effect
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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.
Surinporn Likhitsathian, MD principal investigator
Department of Psychiatry, Faculty of Medicine, Chiang Mai University
4 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 Topiramate in people with Alcohol Dependence, run by Chiang Mai University at 4 sites in Thailand.
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 10 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Alcohol drink/day (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 Jun 2011.