Clinical trial NCT03175549: Medication Development in Alcoholism: Apremilast Versus Placebo
Official title: Medication Development for Protracted Abstinence in Alcoholism: Apremilast Versus Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-06-05
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment, Double Blind, Randomized
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Craving to Drink
timeFrame: 1 hour on the last day of dosing (Day 14)
Secondary outcomes:
measure: Drinking
timeFrame: 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.)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: