Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking

Обзор

The goal of this clinical trial is to learn if, how, and for whom suvorexant (SUV) works to treat alcohol use disorder (AUD). The main questions it aims to answer are: * Is SUV effective for AUD? * Does SUV dampen stress reactivity? * Can the researchers develop a biomarker for SUV treatment response? Researchers will compare SUV to a placebo (a look-alike substance that contains no drug) to see if drug SUV works to treat AUD. Participants will: * Take 10mg capsules of SUV or a placebo orally each night before bedtime for 8-weeks. * Visit the laboratory before (baseline), 4-weeks (mid-point), and 8-weeks (end-point) after taking SUV or placebo that include the psychophysiological stress paradigm (electromyography; EMG). * Complete daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 8-week medication trial.

Вмешательства

• Препарат Suvorexant 10 mg
  This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. Suvorexant (SUV) will be placed in opaque capsules with dextrose filler. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4 weeks. Participants will be provided education about common side effects. At t
• Другое Placebo
  This study is a double-blind study. Participants will complete an initial screening visit and pre-treatment, mid-treatment, and post-treatment lab visits. The placebo pill will be identical in appearance to suvorexant but will contain only dextrose. Following the pre-treatment visit, participants will receive a labeled blister pack with 28 pills and be instructed to take one pill orally about 30 minutes prior to sleep time each night for 4-weeks. Participants will be provided education about com

Первичные конечные точки

• Proportion of Heavy Drinking Days [Срок оценки: 8-week treatment period]
• Startle eyeblink potentiation [Срок оценки: Baseline; 4-weeks; 8-weeks]
• Alcohol Craving Via Ecological Momentary Assessment (EMA) [Срок оценки: 8-week treatment period]

Вторичные конечные точки (5)

• Drinks Per Day [Срок оценки: 8-week treatment period]
• Proportion of Days Abstinent [Срок оценки: 8-week treatment period]
• Transdermal Alcohol Concentration (TAC) [Срок оценки: 8-week treatment period]
• Phosphatidylethanol (PEth) levels [Срок оценки: 4-weeks; 8-weeks]
• Subjective Stress Levels via Ecological Momentary Assessment [Срок оценки: 8-week treatment period]

Критерии участия

Критерии включения

• Generally medically and neurologically healthy;
• Age 18 to 65 at the time of consent;
• Willing and able to give informed consent;
• Current DSM-5 diagnosis of moderate to severe alcohol use disorder;
• Engages in heavy alcohol use defined as drinking ≥14 standard drinks per week if male, and ≥7 standard drinks per week if female;
• Self-reported treatment-seeking for alcohol use disorder

Критерии исключения

• Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function, and/or task performance, and/or interfere with the study protocol, and/or be contraindicated for suvorexant including sleep disorders (e.g., narcolepsy; severe obstructive sleep apnea), hepatic impairment, compromised respiratory function, renal impairment, and endocrine disorders;
• Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder;
• Current substance use disorder (SUD) other than alcohol or mild cannabis use disorder;
• Currently pregnant (positive pregnancy test), lactating, or not agreeing to use birth control methods during the duration of the trial (women);
• Any use of medications for alcohol use disorder or any psychotropic medications (e.g., psychostimulants and benzodiazepines, some antidepressants);
• Current antihistamines use or medication use that may increase risk including, prescribed, over-the-counter, and herbal preparations, as determined by the study physician;
• Current use of strong or moderate inhibitors of CYP3A liver enzymes;
• Current use of strong CYP3A inducers;
• Current use of digoxin;
• Liver function tests more than 3 times the upper limit of normal or elevated bilirubin;
• Engages in night shift work;
• Smoke 10 or more cigarettes (or electronic equivalent) per day and are thus susceptible to acute nicotine withdrawal during lab visits;
• Obesity as defined by a body-mass index (BMI) equal or greater than 30, as calculated from weight and height self-report;
• Clinically significant alcohol withdrawal symptoms the day of the lab sessions, defined as a score >10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar);
• Unwilling/unable to sign the informed consent document;
• Under 18 years old or over 65 years old at the time of enrollment;
• Have attempted suicide in the past 3 years and/or have current suicidal ideation determined as greater than moderate via the Columbia Suicide Severity Rating Scale (C-SSRS)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Ohio State University — Columbus

Идентификаторы

NCT: NCT07214207 · STUDY20250713 · R01AA032711

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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