Apremilast for reducing alcohol craving in adults with alcohol use disorder

Human Laboratory Study of Apremilast for Alcohol Use Disorder

This study will try two daily doses of apremilast versus placebo to see if they reduce alcohol craving in adults with moderate to severe alcohol use disorder.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA) (nih)
• Locations: 3 sites (Los Angeles, California and 2 other locations)
• Trial ID: NCT07325266 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, placebo-controlled human laboratory study compares two maintenance doses of apremilast to matched placebo in adults with moderate-to-severe AUD. Eligible participants (age 21+) who are seeking treatment and meet DSM-5 criteria for AUD are randomized and take daily medication, with the primary outcome being alcohol craving after two weeks of dosing. Secondary outcomes include measures of alcohol consumption, alcohol-related consequences, AUD symptoms, pain, sleep, mood, tobacco and cannabis use, retention, and safety. The trial is conducted at academic sites in Los Angeles (UCLA), Aurora (University of Colorado), and Charlottesville (University of Virginia).

Who should consider this trial

Good fit: Adults aged 21 and older with moderate-to-severe DSM-5 alcohol use disorder who want to reduce or stop drinking and can attend study visits and follow study procedures are the ideal candidates.

Not a fit: People with mild alcohol problems, pregnant or breastfeeding individuals, or those with medical conditions or concomitant medications that make apremilast unsafe may not be helped or eligible.

Why it matters

Potential benefit: If successful, apremilast could offer a new medication option to reduce craving and help people cut back or maintain abstinence from alcohol.

How similar studies have performed: Apremilast, an anti-inflammatory drug used in other conditions, has shown some promise in preclinical work and small human studies for reducing alcohol use, but it is not yet an established treatment for AUD.

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

Where this trial is running

Los Angeles, California and 2 other locations

• University of California — Los Angeles, California, United States (RECRUITING)
• University of Colorado — Aurora, Colorado, United States (RECRUITING)
• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel Falk, PhD — National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Study coordinator: Megan Ryan, MBA

Conditions: Alcohol Use Disorder, Alcohol Misuse