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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT00000450
Eligibility Criteria:
Inclusion Criteria:
* Meets criteria for alcohol dependence.
* Expresses a desire to cut down or stop drinking.
Exclusion Criteria:
* Currently meets criteria for dependence on substances other than alcohol.
* History of opiate dependence or evidence of current opiate use.
* Significant medical disorders that will increase potential risk or interfere with study participation.
* Liver function tests more than 3 times normal or elevated bilirubin.
* Female patients who are pregnant, nursing, or not using a reliable method of birth control.
* Inability to understand and provide a consent form.
* Treatment with an investigational drug during the previous month.
* Prior treatment with naltrexone.
* Chronic treatment with any narcotic-containing medications during the previous month.
* Sensitivity to naltrexone as evidenced by adverse drug experiences especially with narcotic containing analgesics or opioid antagonists.
* Current treatment with disulfiram.
* More than 6 weeks of abstinence.
* Meets criteria for a major psychiatric disorder and is in need of, or currently undergoing pharmacotherapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00000450
Study Brief:
Protocol Section:
NCT00000450