Medication Development in Alcoholism: Apremilast Versus Placebo

NCT03175549 | Completed Phase 2 Results FDA Drug

• 1 other identifier: U01AA025476
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Craving to Drink

  Total Visual Analog Scale (VAS) scores of craving severity in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.

  1 hour on the last day of dosing (Day 14)

Secondary Outcomes (1)

• Drinking

  11 days (Treatment effects on drinking were accessed during the 11 days of ad libidum and did not include the final three days of mandatory abstinence prior to cue reactivity testing on day 14 of dosing.)

Study Arms (2)

Apremilast (Otezla)

ACTIVE COMPARATOR

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

Drug: Apremilast

Placebo

PLACEBO COMPARATOR

Identical placebo pills taken orally for 14 days

Drug: Placebo

Interventions

Apremilast DRUG

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

Also known as: Otezla

Apremilast (Otezla)

Placebo DRUG

Identical placebo pills taken orally for 14 days

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers, 18-65 years of age
• Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS)
• In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
• Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
• Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
• Negative BAC and a CIWA score of \< 9 at time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures.
• In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.
• Females with childbearing potential must have a negative pregnancy test on the screening, randomization, and lab session visits and agree to use effective birth control for the duration required by a given study.
• Able to provide informed consent and understand questionnaires and study procedure
• Willing to comply with the provisions of the protocol and take daily oral medication.

You may not qualify if:

• Active suicidal ideation, as systematically assessed with the Columbia Suicide Severity Rating Scale.
• Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine
• Has a urine drug screen (UDS) positive for substances of abuse other than alcohol.
• Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician
• Known hypersensitivity to apremilast
• Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram \[Antabuse\], naltrexone \[ReVia\], acamprosate \[Campral\], anticonvulsants, or antidepressants).
• Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.
• Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration required by a specific protocol.
• No fixed domicile and/or no availability by home or mobile telephone
• History of hypersensitivity to the study drug or the ingredients.
• Failure to take double-blind medication as prescribed.

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

apremilast; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Barbara J. Mason, Ph.D.
• Organization: The Scripps Research Institute

mason@scripps.edu

858-784-7328

Study Officials

• Barbara J. Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Double Blind, Randomized

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: November 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 16, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)