Apremilast for Alcoholism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of a medication called apremilast in reducing alcohol cravings and consumption in individuals with moderate to severe alcohol use disorder (AUD). Participants will receive either apremilast at one of two doses or a placebo (a pill with no active ingredients) to determine which option best reduces cravings and improves factors like sleep and mood. Ideal candidates have recently experienced AUD symptoms and seek to reduce or stop drinking alcohol. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in AUD treatment.
Will I have to stop taking my current medications?
If you're taking medication for depression, you must have been on a stable dose for at least two months before joining the study and plan to continue it during the study. You cannot take apremilast outside of the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that apremilast, a drug used for other health issues, has been tested for its effects on alcohol use. One study found that apremilast helped people with alcohol use disorder drink less, suggesting it might reduce alcohol cravings.
Regarding safety, the FDA has already approved apremilast for other uses, indicating it has been tested for safety in people with those conditions. While side effects can occur, they are usually known and manageable.
Overall, past studies have shown that apremilast is well-tolerated, and its safety in reducing alcohol cravings is currently under study. Participants should consider this information and consult their healthcare provider before joining a trial.12345Why do researchers think this study treatment might be promising for alcoholism?
Researchers are excited about Apremilast for alcoholism because it introduces a different approach compared to traditional treatments, which often involve behavioral therapies and medications like naltrexone or disulfiram. Apremilast is unique because it targets the immune response and inflammation, potentially addressing underlying biological factors that contribute to alcohol addiction. Unlike many existing treatments, Apremilast might offer a novel mechanism of action by modulating certain pathways in the brain, possibly leading to better outcomes for individuals struggling with alcoholism.
What evidence suggests that apremilast could be an effective treatment for alcohol use disorder?
This trial will evaluate the effectiveness of Apremilast in reducing alcohol consumption. Research has shown that Apremilast might help reduce both the urge to drink alcohol and the amount consumed. In studies, Apremilast lowered alcohol consumption in rats, offering hope for similar results in humans. One study found that it can reduce drinking in people with various levels of alcohol use disorder (AUD). Apremilast affects certain brain pathways that may be linked to alcohol cravings. While more research in humans is needed, these findings suggest it could be a promising treatment for reducing alcohol use. Participants in this trial will receive either 60 mg/day or 90 mg/day of Apremilast, or a matched placebo, to assess its impact on alcohol consumption.12356
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
Citations
Preclinical and clinical evidence for suppression of alcohol ...
These results demonstrate that apremilast suppresses excessive alcohol drinking across the spectrum of AUD severity.
Human Laboratory Study of Apremilast for Alcohol Use ...
The primary outcome measure of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing ...
Apremilast reduces co-occurring alcohol drinking and ...
Apremilast reduced alcohol drinking in both strains of rats. Apremilast reduced mechanical allodynia immediately after drinking, persisting into early and late ...
4.
drugtargetreview.com
drugtargetreview.com/news/160023/repurposed-anti-inflammatory-drug-may-help-treat-alcohol-use-disorders/Repurposed anti-inflammatory drug may help treat alcohol ...
Results showed that apremilast significantly decreased alcohol intake in both male and female rats across both strains. It also reduced pain ...
The FDA-approved drug apremilast suppresses alcohol ...
When given orally prior to the last day of drinking, apremilast (20 mg/kg) was shown to decrease ethanol intake in non-dependent (air control) ...
6.
psoriasiscouncil.org
psoriasiscouncil.org/commentaries/commentary-preclinical-and-clinical-evidence-for-suppression-of-alcohol-intake-by-apremilast/Commentary: Preclinical and Clinical Evidence for ...
The findings demonstrated that apremilast reduced the number of drinks per day relative to the placebo and the probability of a heavy drinking ...
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