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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT03120468
Eligibility Criteria:
Inclusion Criteria:
* Males and females
* Ages 18 and above
* Good physical health
* Current DSM-V diagnosis of alcohol use disorder
* Currently drinking ≥21 alcohol units/week for women and ≥28 alcohol units/week for men on average in the last 28 days prior to screen.
* Be seeking treatment for problems with alcohol
* Be able to take oral medication and be willing to adhere to the medication regimen.
* Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
* Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
* Not have any unresolved legal problems that could jeopardize continuation or completion of the study.
* The pregnancy test for females at screen and prior to randomization must be negative. Additionally, women of childbearing potential must be using an acceptable form of contraception. These include: oral contraceptives, hormonal (levonorgestrel) or surgical implants, or barrier plus spermicide.
Exclusion Criteria:
Please contact site for additional information
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03120468
Study Brief:
Protocol Section:
NCT03120468