Human Laboratory Study of Apremilast for Alcohol Use Disorder

National Institutes of Health (NIH)

Status and phase: Not yet enrolling; Phase 2

Conditions: Alcohol Misuse; Alcohol Use Disorder

Treatments: Drug: Placebo; Drug: Apremilast

Study type: Interventional

Funder types: NIH

Identifiers

NCT07325266

HLAB-004

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups, including a placebo group

Oral Apremilast 60 mg/day

Active Comparator group

Description:

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

Treatment:

Drug: Apremilast

Oral Apremilast 90 mg/day

Active Comparator group

Description:

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

Treatment:

Drug: Apremilast

Oral Matched Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo