NCT07325266 Human Laboratory Study of Apremilast for Alcohol Use Disorder
| NCT ID | NCT07325266 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-04-03 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2026-04-03 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing. Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.
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
Contact & Investigator
Daniel Falk, PhD
PRINCIPAL INVESTIGATOR
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Frequently Asked Questions
Who can join the NCT07325266 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07325266 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07325266 currently recruiting?
Yes, NCT07325266 is actively recruiting participants. Contact the research team at mryan1@nih.gov for enrollment information.
Where is the NCT07325266 trial being conducted?
This trial is being conducted at Los Angeles, United States, Aurora, United States, Charlottesville, United States.
Who is sponsoring the NCT07325266 clinical trial?
NCT07325266 is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The principal investigator is Daniel Falk, PhD at National Institute on Alcohol Abuse and Alcoholism (NIAAA). The trial plans to enroll 100 participants.