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NCT07325266 · ClinicalTrials.gov registry record · Phase 2

Human Laboratory Study of Apremilast for Alcohol Use Disorder

A Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Recruiting
Registry status
Phase 2
Development phase
100
Enrollment target

NCT07325266: Recruiting Phase 2 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

NCT07325266 is a Phase 2 study that is actively recruiting participants, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07325266, a Phase 2 study, is actively recruiting participants, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

RECRUITING
Registry status
Phase 2
Development phase
100 participants
Enrollment target

Study Summary

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.

Primary Outcome

The primary outcome measure of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among participants with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing.

Interventions

  • DRUG Placebo
  • DRUG Apremilast

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2026-04-03
Est. Completion 2027-07-31
Phase Phase 2

What NCT07325266 shows while recruiting

NCT07325266 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07325266 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07325266 about?

NCT07325266 is a clinical study titled "Human Laboratory Study of Apremilast for Alcohol Use Disorder". 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 e...

What is the current status of trial NCT07325266?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2026-04-03. Estimated completion is 2027-07-31.

What interventions are being tested in trial NCT07325266?

The interventions under investigation include: Placebo (DRUG), Apremilast (DRUG).

Who is sponsoring clinical trial NCT07325266?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07325266's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07325266, the US trial registry maintained by the National Library of Medicine. NCT07325266 (mid enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.