Human Laboratory Study of Apremilast for Alcohol Use Disorder

NCT ID: NCT07325266

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-07-31

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.

Conditions

Alcohol Use Disorder; Alcohol Misuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oral Apremilast 60 mg/day

Apremilast, 30mg per capsule, administered twice daily (AM/PM), Placebo, administered once daily (AM)

Group Type: ACTIVE_COMPARATOR

Apremilast

Intervention Type: DRUG

30 mg capsule

Oral Apremilast 90 mg/day

Apremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM)

Group Type: ACTIVE_COMPARATOR

Apremilast

Intervention Type: DRUG

30 mg capsule

Oral Matched Placebo

Placebo, capsule, 2 capsules (AM) and 1 capsule (PM)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched Placebo Capsule

Interventions

Placebo

Matched Placebo Capsule

Intervention Type: DRUG

Apremilast

30 mg capsule

Intervention Type: DRUG

Other Intervention Names

Otezla

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Falk, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Locations

University of California

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Central Contacts

Megan Ryan, MBA

Role: CONTACT

mryan1@nih.gov

3014434225

Other Identifiers

HLAB-004

Identifier Type: -

Identifier Source: org_study_id