Medication Development in Alcoholism: Apremilast Versus Placebo

NCT ID: NCT03175549

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2020-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Apremilast (Otezla)

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

Group Type: ACTIVE_COMPARATOR

Apremilast

Intervention Type: DRUG

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

Placebo

Identical placebo pills taken orally for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical placebo pills taken orally for 14 days

Interventions

Apremilast

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

Intervention Type: DRUG

Placebo

Identical placebo pills taken orally for 14 days

Intervention Type: DRUG

Other Intervention Names

Otezla; Sugar Pill

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

The Scripps Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J. Mason, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Scripps Research Institute

Locations

The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

La Jolla, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01AA025476

Identifier Type: NIH

Identifier Source: org_study_id

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