Alcohol DependencePhase 4THoPA-ONCT01135602
Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
A Phase 4 study testing Topiramate in people with Alcohol Dependence, run by Chiang Mai University at 2 sites in Thailand.
Trial summary
12-week, open-label 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
- 150 participants
- Where
- 2 sitesThailand
- Study dates
- Jul 2010to Mar 2012
- Phase
- Phase 4
- 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 problems
- DSM-IV-TR alcohol dependence
- >/= 35 drinks/week (male) or >/= 28 drinks/week (female) for >/= 1 week during four weeks prior to the admission
- AUDIT score >/= 8
- Mild or no alcohol withdrawal
- Body mass index > 18 kg/m2
- No pregnancy and no plan for pregnancy (female)
- 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, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- Moderate to high risk of suicide
- Medical history of narrow angle glaucoma, renal impairment, kidney stones, and seizures
- Unstable medical conditions
Show all 10Show fewer
- Plan to receive a formal treatment for alcoholism from other treatment settings
- Under legal process
- Pregnancy and nursing woman
- Abnormal laboratory tests, including blood urea nitrogen, creatinine, electrolytes, and fasting blood sugar
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Not yet recruiting
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200
Manit Srisurapanont, MD, 6653945422, msrisu@yahoo.com
Pichai Sangchanchai, MD
- Recruiting
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200
Manit Srisurapanont, MD, +66-53-945422, msrisu@yahoo.com
Manit Srisurapanont, MD
About this study
Official title: Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study
12-week, open-label 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 50-300 mg/day Orally Twice per day
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | 1 group Receives: Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)
Measured: 12 weeks
Secondary outcomes (1)
Alcohol drink/day
Alcohol drink/day assessed by the use of Timeline Followback (TLFB)
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 posted3 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012 (estimated)
- Study completionMar 2012 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Investigators
- Manit Srisurapanont, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135602
- Sponsor's protocol ID
- THoPA-O
- Acronym
- THoPA-O
- Status last verified
- Jun 2010
- First submitted
- 2 Jun 2010
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study
- ClinicalTrials.gov ID
- NCT01135602
- Acronym / sponsor ID
- THoPA-O / THoPA-O
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol dependence, Alcoholism, Topiramate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 3 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.
12-week, open-label study of topiramate in hospitalized patients with alcoholism
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: Topiramate1 group |
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 problems
- DSM-IV-TR alcohol dependence
- >/= 35 drinks/week (male) or >/= 28 drinks/week (female) for >/= 1 week during four weeks prior to the admission
- AUDIT score >/= 8
- Mild or no alcohol withdrawal
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, systematic steroids, carbonic anhydrase inhibitors, hydrochlorthiazide, metformin, pioglitazone, or disulfiram
- Moderate to high risk of suicide
- 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 50-300 mg/day Orally Twice per day | Drug | Topiramate |
Primary outcome
Cognition
Time frame: 12 weeks
Cognition will be assessed by the use of Montreal Cognitive Assessment (MoCA)
1 secondary outcome
Alcohol drink/day
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
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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.
Manit Srisurapanont, MD principal investigator
Department of Psychiatry, Faculty of Medicine, Chiang Mai University
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 Dependence, run by Chiang Mai University at 2 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: status not confirmed, as of the sponsor's last update on 15 Aug 2011. 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 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manit Srisurapanont, MD (6653945422, msrisu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition (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 15 Aug 2011.