Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study

NCT ID: NCT01135602

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

12-week, open-label study of topiramate in hospitalized patients with alcoholism

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Topiramate

1 group

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

Topiramate 50-300 mg/day Orally Twice per day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topiramate

Topiramate 50-300 mg/day Orally Twice per day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Topamax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chiang Mai University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Manit Srisurapanont, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Faculty of Medicine, Chiang Mai University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, Thailand

Site Status NOT_YET_RECRUITING

Maharaj Nakorn Chiang Mai Hospital

Muang, Chiang Mai, Thailand

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Manit Srisurapanont, MD

Role: CONTACT

6653945422

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Manit Srisurapanont, MD

Role: primary

6653945422

Manit Srisurapanont, MD

Role: primary

+66-53-945422

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

THoPA-O

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Topiramate Treatment of Problem Drinkers
NCT00626925 COMPLETED PHASE4
Topiramate on Gambling-Related Behaviours
NCT00370188 WITHDRAWN PHASE2
New Treatment for Alcohol and Nicotine Dependence
NCT01182766 COMPLETED PHASE2/PHASE3