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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00655967
Eligibility Criteria:
Inclusion Criteria:
1. Patients, men and women, age 60 and older.
2. Patients with Alcohol Dependence as determined by SCID I section for substance use disorders who are not in full sustained remission.
3. Patients who have consumed significant amounts of alcohol in the past 30 days, as determined by Time Line Follow Back report by patient and patient's spouse, partner or friend. Significant amounts is defined for these purposes as at least one episode of 5 or more drinks, with a drink defined as one bottle of beer, one glass of wine or one shot of liquor.
4. Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
5. Patients, who signed the written informed consent given prior to entering any study procedure and completed the informed consent quiz.
Exclusion Criteria:
1. Patients with the following concurrent DSM-IV Axis I diagnoses as determined by the relevant sections of SCID I:
* Current, acute psychosis regardless of etiology
* Moderate to severe dementia regardless of etiology, defined as a MMSE score of 18 or less out of 30.
* Current opioid, cocaine or amphetamine dependence, defined as not meeting criteria for sustained full remission.
2. Patients with significant or unstable medical conditions as determined by investigator. This is defined as a medical condition that, in the Investigator's opinion, would expose them to an increased risk of a significant adverse event or interfere with assessments of safety during the course of the trial.
3. Patients with significantly abnormal lab values, as determined by the investigator, including creatinine clearance less than 30 as determined by Cockcroft-Gault estimate.
4. Patients with a history of intolerance or hypersensitivity to acamprosate.
5. Patients who are actively suicidal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT00655967
Study Brief:
Protocol Section:
NCT00655967