NCT07325266

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
15mo left

Started Apr 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Jul 2027

First Submitted

Initial submission to the registry

January 6, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 3, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

January 6, 2026

Last Update Submit

April 30, 2026

Conditions

Alcohol Use DisorderAlcohol Misuse

Outcome Measures

Primary Outcomes (1)

  • Alcohol Craving

    The primary outcome measure of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among participants with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.

    Week 4

Secondary Outcomes (18)

  • Participants with no heavy drinking days

    Weeks 2-5

  • Participants abstinent from alcohol

    Weeks 2-5

  • Days abstinent from alcohol per week.

    Weeks 2-5

  • Participants with at least a WHO 2-level decrease in alcohol consumption

    Weeks 2-5

  • Heavy drinking days per week

    Weeks 2-5

  • +13 more secondary outcomes

Study Arms (3)

Oral Apremilast 60 mg/day

ACTIVE COMPARATOR

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

Drug: Apremilast

Oral Apremilast 90 mg/day

ACTIVE COMPARATOR

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

Drug: Apremilast

Oral Matched Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PlaceboDRUG

Matched Placebo Capsule

Oral Matched Placebo
ApremilastDRUG

30 mg capsule

Also known as: Otezla
Oral Apremilast 60 mg/dayOral Apremilast 90 mg/day

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 21 years of age.
  • 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).
  • 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).
  • Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
  • 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.
  • 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.
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California

Los Angeles, California, 90095, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22911, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

apremilast

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Daniel Falk, PhD

    National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Ryan, MBA

CONTACT

3014434225mryan1@nih.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 8, 2026

Study Start

April 3, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

US(3)