Apremilast for Alcohol Use Disorder Treatment in Women and Men

NCT06324435 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: 20000374391U54AA027989-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol Consumption

  Means mls of alcohol consumed during 120 minute alcohol self-administration sessions with personalized stress imagery vs neutral/relaxing imagery taking place at steady state.

  120 minutes

Study Arms (1)

Apremilast

EXPERIMENTAL

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 20mg 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

Interventions

Apremilast DRUG

60mg/day

Also known as: Otezla

Apremilast

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 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 a medication regimen.

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• 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 treatment 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.
• Those currently in treatment for alcohol use, individuals with a history of serious withdrawal, and individuals who have repeatedly undergone alcohol detoxification.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Office of Research on Women's Health (ORWH): collaborator
• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 22, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)