Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study
Information source: Chiang Mai University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence
Intervention: Topiramate (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Chiang Mai University Official(s) and/or principal investigator(s):
Manit Srisurapanont, MD, Principal Investigator, Affiliation: Department of Psychiatry, Faculty of Medicine, Chiang Mai University
Overall contact:
Manit Srisurapanont, MD, Phone: 6653945422, Email: msrisu@yahoo.com
Summary
12-week, open-label study of topiramate in hospitalized patients with alcoholism
Clinical Details
Official title: Topiramate for Hospitalized Patients With Alcoholism: a 12-Week Open-Label Study
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cognition
Secondary outcome: Alcohol drink/day
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Manit Srisurapanont, MD, Phone: 6653945422, Email: msrisu@yahoo.com
Maharaj Nakorn Chiang Mai Hospital, Muang, Chiang Mai 50200, Thailand; Not yet recruiting
Manit Srisurapanont, MD, Phone: 6653945422, Email: msrisu@yahoo.com
Pichai Sangchanchai, MD, Sub-Investigator
Maharaj Nakorn Chiang Mai Hospital, Muang, Chiang Mai 50200, Thailand; Recruiting
Manit Srisurapanont, MD, Phone: +66-53-945422, Email: msrisu@yahoo.com
Manit Srisurapanont, MD, Principal Investigator
Additional Information
Starting date: July 2010
Last updated: August 12, 2011
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