Medication Development in Alcoholism: Apremilast Versus Placebo

Part of paid clinical trials in La Jolla, California.

Sponsor
The Scripps Research Institute
Study ID
NCT03175549
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Apremilast — DRUG
    Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
  • Placebo — DRUG
    Identical placebo pills taken orally for 14 days

Study Details

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.

Key Dates

First listed
Jun 5, 2017
Start date
Nov 1, 2017
Status verified
Aug 2022
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Apremilast (Otezla)
    Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
  • Placebo Comparator: Placebo
    Identical placebo pills taken orally for 14 days

Primary Outcome Measure

Craving to Drink [ Time Frame: 1 hour on the last day of dosing (Day 14) ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Scripps Research Institute Pearson Center for Alcoholism and Addiction ResearchLa JollaCalifornia92037-

Find similar trials in La Jolla, CA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research· La Jolla, CA

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