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Medication Development in Alcoholism: Apremilast Versus Placebo

NCT03175549 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2022-09-16

Study results available
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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.

Conditions

Interventions

DRUG

Apremilast

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

DRUG

Placebo

Identical placebo pills taken orally for 14 days

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • The Scripps Research Institute

    lead OTHER

Principal Investigators

  • Barbara J. Mason, Ph.D. · The Scripps Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-04-01
Completion
2020-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175549 on ClinicalTrials.gov