Orexin Receptor Antagonism for the Treatment of Alcohol Use Disorder and Stress-Related Drinking
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Proportion of Heavy Drinking Days
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Control
Individuals will take a placebo pill daily for 8-weeks.
干预措施: Placebo (Other)
Suvorexant
Individuals will take 10mg of suvorexant (Merck & Co Inc.) daily for 8-weeks.
干预措施: Suvorexant 10 mg (Drug)
结局指标
主要结局
Proportion of Heavy Drinking Days
时间窗: 8-week treatment period
Self-reported heavy drinking days defined as 5+ drinks for men and 4+ for women. Reported outcome measured as proportion of heavy drinking days.
Startle eyeblink potentiation
时间窗: Baseline; 4-weeks; 8-weeks
Startle eyeblink potentiation will be collected during the NPU threat task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.
Alcohol Craving Via Ecological Momentary Assessment (EMA)
时间窗: 8-week treatment period
Participants will rate the intensity of their alcohol cravings using a Likert scale of 1 (lowest craving) -7 (highest craving).
次要结局
- Drinks Per Day(8-week treatment period)
- Proportion of Days Abstinent(8-week treatment period)
- Transdermal Alcohol Concentration (TAC)(8-week treatment period)
- Phosphatidylethanol (PEth) levels(4-weeks; 8-weeks)
- Subjective Stress Levels via Ecological Momentary Assessment(8-week treatment period)
研究者
Stephanie M Gorka, PhD
Associate Professor
Ohio State University