The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Percent Drinking Days
研究概览
简要总结
To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with alcohol use disorder (AUD).
详细描述
The study aims to examine the effects of PREG on a) alcohol craving, mood and neuroendocrine reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily alcohol intake, craving, cognition and mood in men and women with AUD; and c) sex differences in all of these outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female individuals, ages 18 to
- •Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.
- •Subject has voluntarily given informed consent and signed the informed consent document.
- •Able to read English and complete study evaluations.
排除标准
- •Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
- •Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.
- •Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).
- •Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.
- •Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.
- •Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
- •Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
研究组 & 干预措施
patients receiving 300mg PREG
Patients randomly assigned to receive 300mg of pregnenolone (PREG) daily.
干预措施: Pregnenolone300 (Drug)
patients receiving 500mg PREG
Patients randomly assigned to receive 500mg of pregnenolone (PREG) daily.
干预措施: Pregnenolone500 (Drug)
placebo
Patients randomly assigned to receive a placebo daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Drinking Days
时间窗: up to 8 weeks
The mean percent drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
Percent Heavy Drinking Days
时间窗: up to 8 weeks
The mean percent heavy drinking days as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
Number of Drinks Per Drinking Day
时间窗: up to 8 weeks
Average number of drinks per drinking day as assessed by self report on daily smartphone monitoring and corroborated by the Substance Use Calendar over the 8 week period.
次要结局
- Alcohol Craving(8 week outcome period)
- Number of Participants With Treatment Emergent Adverse Events(up to 8 weeks)
- Pregnenolone Levels(up to 8 weeks)
- Weekly Negative Mood and Anxiety(assessed weekly, score at week 8 reported)