Идёт набор NCT07325266

Human Laboratory Study of Apremilast for Alcohol Use Disorder

Фаза II С лечением Alcohol Use Disorder Alcohol Misuse

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Placebo, Apremilast.
Кому может быть актуально: Состояния в реестре: Alcohol Use Disorder, Alcohol Misuse. Базовые параметры: от 21 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Primary: The primary objective of this study is to compare the efficacy of two different maintenance doses of apremilast (tablets) in reducing alcohol craving among subjects with moderate to severe alcohol use disorder (AUD) after two weeks of daily dosing. Secondary: Secondary objectives include evaluation of two different maintenance doses of apremilast compared with matched placebo on other measures of self-reported alcohol consumption, alcohol craving, alcohol-related negative consequences, AUD symptoms, pain, sleep disturbances, depression, anxiety, quality of life, cigarette smoking, other nicotine use, cannabis use, retention in the study, and safety.

Вмешательства

Препарат Placebo
Matched Placebo Capsule
Препарат Apremilast
30 mg capsule

Первичные конечные точки

Alcohol Craving [Срок оценки: Week 4]

Вторичные конечные точки (12)

Participants with no heavy drinking days [Срок оценки: Weeks 2-5]
Participants abstinent from alcohol [Срок оценки: Weeks 2-5]
Days abstinent from alcohol per week. [Срок оценки: Weeks 2-5]
Participants with at least a WHO 2-level decrease in alcohol consumption [Срок оценки: Weeks 2-5]
Heavy drinking days per week [Срок оценки: Weeks 2-5]
Participants abstinent from cigarette smoking [Срок оценки: Weeks 4-5]
Number of drinks per week [Срок оценки: Weeks 2-5]
Number of drinks per drinking day [Срок оценки: Weeks 2-5]
Alcohol Use Disorder Symptoms [Срок оценки: Week 6]
Number of days of cannabis use per week [Срок оценки: Weeks 4-6]
Global Health Score [Срок оценки: Weeks 4,6]
Alcohol Negative Consequences Score [Срок оценки: Weeks 4,6]

Критерии участия

Inclusion Criteria (not exhaustive list):

Be at least 21 years of age.
Have a current (past 12 months) DSM-5 diagnosis of AUD (4 or more symptoms) assessed using the MINI neuropsychiatric interview version 7.0.2 (at least moderate severity).
Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent).
Be seeking treatment for problems with alcohol and express a goal of abstinence or a reduction in drinking.
Be able to verbalize an understanding of the consent form, able to provide written informed consent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
Agree (if the participant is female and of childbearing potential) to use at least one of the following methods of birth control, unless she is surgically sterile, partner is surgically sterile or she is postmenopausal:

oral contraceptives,
contraceptive sponge,
patch,
double barrier (diaphragm/spermicidal or condom/spermicidal),
intrauterine contraceptive system,
etonogestrel implant,
medroxyprogesterone acetate contraceptive injection,
complete abstinence from sexual intercourse, and/or
hormonal vaginal contraceptive ring.
Be willing to adhere to the investigational product dosing schedule.
Complete all assessments required at screening and baseline.
Have a place to live in the 2 weeks prior to randomization and not be at risk that s/he will lose his/her housing by Study Week 6.
Not anticipate any significant problems with transportation arrangements or available time to travel to the study site by Study Week 6.
Not have any plans to move within Study Week 6 to a location which would make continued participation in the study impractical.
Provide contact information of someone, such as a family member, spouse, or significant other, who may be able to contact the participant in case of a missed clinic appointment.
Be someone who in the opinion of the investigator would be expected to complete the study protocol.
Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
If taking a medication for depression, must have been taking a stable dose in the 2-months prior to randomization and plan to continue during the study. This includes drugs such as the following:

SSRIs
Dual uptake inhibitors
SNRIs
Tricyclic antidepressants
MAOIs
Bupropion
Not currently taking apremilast and agree not to take non-study supplied apremilast for the duration of the study.
Have normal renal function defined as creatinine clearance ≥ 60 mL per minute by the Cockcroft-Gault equation.