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Apremilast for Alcoholism

Phase 1
Recruiting
Led By Sherry McKee, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 21-65.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights
No Placebo-Only Group

Summary

"This trial will collect initial data to study the effects of taking 60mg of apremilast per day in adults with Alcohol Use Disorders."

Who is the study for?
This trial is for adults aged 21-65 with Alcohol Use Disorders (AUD) who meet specific drinking criteria. Participants must be able to handle responsibilities the day after a session, comply with study procedures, take oral medications, and provide informed consent. It's not suitable for those unable to fulfill these requirements.
What is being tested?
The trial is testing Apremilast (60mg/day) as a potential treatment for AUD in both women and men. The goal is to collect preliminary data on its effectiveness and safety for individuals struggling with alcohol consumption issues.
What are the potential side effects?
While the side effects of Apremilast in this context are not detailed here, common ones may include gastrointestinal symptoms like diarrhea or nausea, headaches, and potential mood changes. Each person's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Alcohol Consumption

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309
30%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
viral gastroenteritis
5%
cyst left inner thigh
5%
abscess right hand
5%
right flank pain
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ApremilastExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
2017
Completed Phase 4
~2300

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,648 Total Patients Enrolled
91 Trials studying Alcoholism
10,967 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,760 Total Patients Enrolled
456 Trials studying Alcoholism
823,776 Patients Enrolled for Alcoholism
Office of Research on Women's Health (ORWH)NIH
32 Previous Clinical Trials
36,101 Total Patients Enrolled
~3 spots leftby Feb 2025
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