Efficacy of Topiramate for Hospitalized Patients With Alcoholism (ETHoPA-R)
This study has been completed.
Sponsor:
Chiang Mai University
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01145677
First received: June 16, 2010
Last updated: June 22, 2011
Last verified: June 2010
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Purpose
This is a 12-Week, randomized controlled study of topiramate in hospitalized patients with alcoholism
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Topiramate |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Randomized, Placebo-Controlled Trial |
Resource links provided by NLM:
MedlinePlus related topics:
Alcoholism
Drug Information available for:
Topiramate
U.S. FDA Resources
Further study details as provided by Chiang Mai University:
Primary Outcome Measures:
- Alcohol drink/day [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Alcohol drink/day assessed by the use of time line follow back
Secondary Outcome Measures:
- Common adverse effect [ Time Frame: 12 week ] [ Designated as safety issue: Yes ]Common adverse effect will be assessed by the use of questionaire and self-report
| Enrollment: | 90 |
| Study Start Date: | June 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Topiramate |
Drug: Topiramate
Topiramate 100-300 mg/day orally twice per day
Other Name: Topamax
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
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, 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01145677
Locations
| Thailand | |
| Chiang Mai Drug Dependence Treatment Center | |
| Maerim, Chiang Mai, Thailand, 50180 | |
| Maharaj Nakorn Chiang Mai Hospital | |
| Muang, Chiang Mai, Thailand, 50200 | |
| Maharaj Nakorn Chiang Mai Hospital | |
| Muang, ChiangMai, Thailand, 50200 | |
| Suanprung Psychiatric Hospital | |
| Muang, ChiangMai, Thailand, 50100 | |
Sponsors and Collaborators
Chiang Mai University
Investigators
| Principal Investigator: | Surinporn Likhitsathian, MD | Department of Psychiatry, Faculty of Medicine, Chiang Mai University |
More Information
No publications provided
| Responsible Party: | Surinporn Likhitsathian, Department of Psychiatry, Faculty of Medicine, Chiang Mai University |
| ClinicalTrials.gov Identifier: | NCT01145677 History of Changes |
| Other Study ID Numbers: | THoPA-R |
| Study First Received: | June 16, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Thailand: Ministry of Public Health |
Keywords provided by Chiang Mai University:
|
Alcohol dependence Alcoholism Topiramate |
Additional relevant MeSH terms:
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Topiramate Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |
ClinicalTrials.gov processed this record on May 19, 2013