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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07325266
Eligibility Criteria:
Inclusion Criteria (not exhaustive list):
1. Be at least 21 years of age.
2. Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity).
3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
4. Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
5. 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.
6. Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:
* oral contraceptives,
* contraceptive sponge,
* patch,
* double barrier (diaphragm/spermicidal or condom/spermicidal),
* intrauterine contraceptive system,
* etonogestrel implant,
* medroxyprogesterone acetate contraceptive injection,
* complete abstinence from sexual intercourse, and/or
* hormonal vaginal contraceptive ring.
7. Be willing to adhere to the investigational product dosing schedule.
8. Complete all assessments required at screening and baseline.
9. Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 6.
10. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6.
11. Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical.
12. Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment.
13. Be someone who in the opinion of the investigator would be expected to complete the study protocol.
14. 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.
15. If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:
* SSRIs
* Dual uptake inhibitors
* SNRIs
* Tricyclic antidepressants
* MAOIs
* Bupropion
16. Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study.
17. Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.
Exclusion Criteria:
Contact study site for exclusion criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07325266
Study Brief:
Protocol Section:
NCT07325266