The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Craving Change in Stress and Cue Relative to Neutral
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 cocaine use disorder (CUD).
详细描述
This experimental study aims to examine the effects of PREG on a) repeated cocaine craving, mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and mood in men and women with CUD; and c) sex differences in all of these outcomes. The study's hypothesis is that PREG vs PLA will dose-specifically decrease stress-induced and drug-cue induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic pituitary adrenal (HPA) axis response to stress and drug-cue imagery, and reduce cocaine intake and craving in daily life in individuals with CUD.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（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 DSM-V criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine 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/PCP, excluding alcohol and nicotine.
- •Any current use of opiates or past history of opiate use disorder.
- •Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
- •Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
- •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.
- •Abstinent from cocaine for more than two weeks prior to admission.
- •Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
研究组 & 干预措施
PREG 300
Eligible participants will be randomly assigned to PREG 300 mg/day over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
干预措施: Pregnenolone (PREG) (Drug)
patients receiving placebo
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
干预措施: Placebos (Drug)
PREG 500
Eligible participants will be randomly assigned to PREG 500 mg/day over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
干预措施: Pregnenolone (PREG) (Drug)
结局指标
主要结局
Craving Change in Stress and Cue Relative to Neutral
时间窗: Experiment during treatment week 2
Cocaine craving assessed in a laboratory experiment with exposure to stress, cocaine cue and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo. Cocaine craving was assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale that ranges in mean score from 1 to 7, where a higher score indicates higher craving. Data presented here is craving change in stress relative to neutral and craving change in cue relative to neutral, where the possible range in mean change score is -6 to +6.
次要结局
- Anxiety Change in Stress and Cue Relative to Neutral(Experiment during treatment week 2)
- Cortisol Level Change in Stress and Cue Relative to Neutral(Experiment during treatment week 2)
- Pregnenolone Concentration(between weeks 2-3 of treatment)