CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Apremilast +1 moredrug
Likely dose
Apremilast 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03175549
NCT03175549Phase 2Completed
CompareCT.gov

Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo

The Scripps Research Institute·interventional·Posted Jun 5, 2017·Updated Sep 16, 2022

In Brief

A Phase 2 clinical trial evaluating Apremilast and Placebo for Alcohol Use Disorder. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 5, 2017
Enrollment StartNov 1, 2017
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 9.1 years ago

Interventions

Apremilastdrug

Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.

Placebodrug

Identical placebo pills taken orally for 14 days