Apremilast for reducing alcohol craving in adults with alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: mryan1@nih.gov
• Phone: 3014434225

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.