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 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00000456
Eligibility Criteria:
Inclusion Criteria:
* Meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification.
* Consumes on average five standard drinks per day.
* Able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements.
* Able to read and understand questionnaires and informed consent.
* Lives within 50 miles of the study site.
Exclusion Criteria:
* Currently meets criteria for any other psychoactive substance dependency disorder.
* Ever abused opiates.
* Used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen.
* Meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
* Meets criteria for dissociate disorder or eating disorders.
* Has current suicidal or homicidal ideation.
* Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
* Current use of disulfiram (Antabuse).
* Clinically significant medical problems that would impair participation or limit medication ingestion.
* Hepatocellular disease.
* Sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
* Have current charges pending for a violent crime.
* Does not have a stable living situation and a reliable source of collateral reporting.
* Has taken an opiate antagonist drug in the last month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT00000456
Study Brief:
Protocol Section:
NCT00000456