Topiramate for Hospitalized Patients With Alcoholism: a 12-week Study (THoPA-O)

Chiang Mai University

Status and phase: Unknown; Phase 4

Conditions: Alcohol Dependence

Treatments: Drug: Topiramate

Study type: Interventional

Funder types: Other

Identifiers

NCT01135602

THoPA-O

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Topiramate

Experimental group

Description:

1 group

Treatment:

Drug: Topiramate