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Medication Development in Alcoholism: Apremilast Versus Placebo

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Apremilast
Placebo
Sponsored by
The Scripps Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Apremilast (Otezla)

Placebo

Arm Description

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

Identical placebo pills taken orally for 14 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Drinking
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value. 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.

Full Information

First Posted
June 1, 2017
Last Updated
August 22, 2022
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03175549
Brief Title
Medication Development in Alcoholism: Apremilast Versus Placebo
Official Title
Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment, Double Blind, Randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apremilast (Otezla)
Arm Type
Active Comparator
Arm Description
Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical placebo pills taken orally for 14 days
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla
Intervention Description
Fixed oral dose of 90 mg/d following the standard titration for a total dosing duration of 14 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Identical placebo pills taken orally for 14 days
Primary Outcome Measure Information:
Title
Craving to Drink
Description
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.
Time Frame
1 hour on the last day of dosing (Day 14)
Secondary Outcome Measure Information:
Title
Drinking
Description
Number of standard drinks per day using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per day with a minimum value of 0 and an undetermined maximum value. 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.
Time Frame
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.)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Medication Development in Alcoholism: Apremilast Versus Placebo

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