Status:
WITHDRAWN
Safety of Acamprosate for Alcohol Dependence in the Elderly: An Open-Label Study (SAFADIE)
Lead Sponsor:
University of New Mexico
Conditions:
Alcohol Dependence
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Alcohol abuse and dependence are very prevalent and result in significant morbidity, mortality and cost to society (Harwood 2000). Pharmacotherapies to assist with alcohol dependence consist of disulf...
Detailed Description
STUDY DESIGN: This trial will be conducted as an open-label, fixed dose design for safety of Acamprosate in the elderly. Subjects will receive Acamprosate for 12 weeks. The schedule of visits will inc...
Eligibility Criteria
Inclusion
- Patients, men and women, age 60 and older.
- Patients with Alcohol Dependence as determined by SCID I section for substance use disorders who are not in full sustained remission.
- 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.
- Patients, who are able to comprehend and satisfactorily comply with protocol requirements.
- Patients, who signed the written informed consent given prior to entering any study procedure and completed the informed consent quiz.
Exclusion
- 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.
- 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.
- Patients with significantly abnormal lab values, as determined by the investigator, including creatinine clearance less than 30 as determined by Cockcroft-Gault estimate.
- Patients with a history of intolerance or hypersensitivity to acamprosate.
- Patients who are actively suicidal.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00655967
Start Date
December 1 2006
End Date
December 1 2006
Last Update
August 1 2023
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131-0001