Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01135602
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01135602
Study Brief:
Protocol Section:
NCT01135602