Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder

NCT07029529 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 20000403912U54AA027989-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

For this protocol, the investigators plan to collect data to evaluate apremilast (60mg/day) vs placebo in adults with Alcohol Use Disorders (AUD).

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol Consumption

  For the ad-libitum drinking sessions (120 mins), the primary outcome variable will be calculated as percent milliliters consumed = number of milliliters consumed/total amount available.

  Lab Sessions (Days 10, 17 & 24)

Study Arms (2)

Apremilast 60mg/day

ACTIVE COMPARATOR

Apremilast 60mg/day. Administered orally twice daily at 8:00 AM and 8:00 PM while titrating to the full dose. Titration schedule: Day 1 10mg AM; Day 2 10mg AM, 10mg PM; Day 3 10mg AM, 20mg PM; Day 4 20mg AM, 20mg PM; Day 5 20 mg AM, 30mg PM; Day 6 30mg AM, 30mg PM. Once at steady state, administration is orally twice daily at 8:00 AM (30mg) and 8:00 PM (30mg).

Drug: Apremilast 60mg

Placebo

PLACEBO COMPARATOR

Administered orally twice daily at 8:00 AM and 8:00 PM.

Other: Placebo

Interventions

Apremilast 60mg DRUG

Apremilast 60mg/day

Also known as: Otezla

Apremilast 60mg/day

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65.
• Able to read and write English.
• Meets DSM-5 criteria for current (past 6 months) AUD.
• Drinking criteria: males - drinks \> 14 drinks per week and exceeds 4 drinks per day at least twice per week; females - drinks \> 7 drinks per week and exceeds 3 drinks per day at least twice per week. They must meet drinking criteria during a consecutive 30-day period prior to baseline.
• Laboratory sessions will be scheduled such that subjects will not have major responsibilities on the following day which might limit drinking during the self-administration session (e.g., job interview, exam).
• Able to take oral medications and willing to adhere to medication regimen.
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study

You may not qualify if:

• Subjects with any significant current medical conditions (neurological, cardiovascular, endocrine, thyroid, renal, liver), seizures, delirium or hallucinations, or other unstable medical conditions, including HIV.
• Current DSM-5 substance use disorder (other than AUD or tobacco use disorder).
• A positive test result at intake appointment on urine drug screens conducted for illicit drugs.
• Past 30-day use of psychoactive drugs may be included at the discretion of the study MD as long as the concurrent treatment does not compromise the study integrity by virtue of its type, duration, or intensity.
• Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or her partner is surgically sterile or she is postmenopausal (hormone contraceptives \[oral, implant, injection, patch, or ring\], contraceptive sponge, double barrier \[diaphragm or condom plus spermicide\], or IUD).
• Suicidal, homicidal, or evidence of current (past 6 months) mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders.
• Only one member per household can participate in the study.
• Drugs that may influence study outcomes (e.g., disulfiram, naltrexone, acamprosate, anticonvulsants).
• Subjects likely to exhibit clinically significant alcohol withdrawal during the study. We will exclude subjects who a) have a history of perceptual distortions, seizures, delirium, or hallucinations upon withdrawal, or b) have a score of \> 8 on the Clinical Institute Withdrawal Assessment scale at intake appointments.
• Subjects who have taken any investigational drug within 4 weeks immediately preceding admission to the study period.
• Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current application.
• Individuals who are currently in treatment for drinking or who have attempted to quit drinking within the past 3 months in order to exclude participants seeking treatment.
• Individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

apremilast

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sherry McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meaghan Lavery

CONTACT

203-737-2783; meaghan.lavery@yale.edu

Sabrina Coppola

CONTACT

203-737-2827; sabrina.coppola@yale.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: May 12, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)