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:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02090504
Eligibility Criteria:
Inclusion Criteria:
* age range 21-75,
* diagnosis of alcohol dependence according to DSM-IV criteria
* the presence of AWS as assessed by Clinical Institute Withdrawal Assessment for Alcohol-revised (CIWA-Ar) scale, a scoring system for quantitative evaluation of physical symptoms of AWS.20 Only subjects with a CIWA-Ar score equal to or higher than 10 (defined as moderate or severe AWS requiring pharmacological treatment) were ultimately enrolled in the study.
Exclusion criteria:
* ≤55 kg of body weight;
* history of withdrawal fits within 24 hours pre-study;
* history of epilepsy or epileptics seizures not properly controlled by established anti-epileptic treatment;
* dependence from narcotics, BDZs or other drugs of abuse;
* documented pre-existent hypersensitivity to SMO or to BDZs,
* renal failure (blood creatinine \>2•5 mg/dl and/or documented proteinuria \>500 mg/die),
* heart failure,
* severe respiratory failure
* hepatic encephalopathy stage II-IV;
* psychiatric disorders requiring treatment with psychoactive medications before the start of the study;
* treatment with clonidine, haloperidol, bromocriptine during the last 3 months prior to participation in the study;
* participation to other clinical investigations in the previous month prior to recruitment;
* females whose could not assure not to become pregnant during the 1 month period of treatment, and during the subsequent 3 weeks;
* subjects without a stable social condition or homeless.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT02090504
Study Brief:
Protocol Section:
NCT02090504