Apremilast for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Daniel Falk, PhD
Principal Investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Are You a Good Fit for This Trial?
This trial is for adults over 21 with moderate to severe alcohol use disorder (AUD) who want to reduce or stop drinking. They must understand and consent to the study, be sober at enrollment, and agree to use reliable contraception. It's not specified who can't join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily dosing of apremilast or placebo to evaluate efficacy in reducing alcohol craving
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Apremilast
Trial Overview
The study tests two doses of Apremilast tablets against a placebo in reducing alcohol cravings after two weeks. It also looks at effects on alcohol consumption, negative consequences, AUD symptoms, pain, sleep, mood disorders, quality of life and other substance uses.
How Is the Trial Designed?
3
Treatment groups
Active Control
Placebo Group
Apremilast, 30mg per capsule, administered twice daily (AM/PM), Placebo, administered once daily (AM)
Apremilast, 30mg per capsule, 2 capsules (AM) and 1 capsule (PM)
Placebo, capsule, 2 capsules (AM) and 1 capsule (PM)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead Sponsor
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