The Effect of Ketamine on Reducing Cue Reactivity in Cocaine Users
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in Cue Reactivity
研究概览
简要总结
Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators, studies with human subjects have been unsuccessful to date. The purpose of this investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.
详细描述
In this study, volunteers will undergo a 9 day inpatient trial during which they will receive three counter-balanced infusions (two doses of ketamine and a dose of lorazepam) on three separate days in a within-subject, double-blind, controlled design. Of the various glutamate antagonists available for human use, ketamine will be utilized because its safety profile, pharmacokinetics, and range of tolerable sub-anesthetic dosings have been very well studied. Also, ketamine has shown promise in managing opiate and alcohol use disorders in certain studies, and may therefore be the most likely glutamate antagonist to dampen cue reactivity and increase motivation in cocaine users. If ketamine significantly improves these deficits, this would suggest that the drug should be investigated further for potential utility as a treatment for cocaine dependence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Seeking treatment or abstinence
- •DSM IV criteria for substance dependence (other than methamphetamine, cocaine, cannabis, or nicotine), or DSM IV criteria for abuse of ketamine or lorazepam
- •DSM-IV criteria for other Axis I psychiatric illness that may make participation hazardous such as schizophrenia, schizoaffective disorder, psychosis NOS, MDD, psychosis secondary to substances, or bipolar disorder
- •Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
- •Current suicide risk or a history of suicide attempt within the past 2 years
- •Current use of prescribed psychotropic medication
- •Pregnancy, nursing, or had a baby within the past 6 mo.
- •Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
- •Unstable physical disorders which might make participation hazardous such as end-stage AIDS, hypertension (>140/90), anemia, active hepatitis or other liver disease, or diabetes
- •"Bad" reaction/experience with prior exposure to ketamine or lorazepam
- •History of significant violence
- •First degree relative with a psychotic disorder
研究组 & 干预措施
K1
Ketamine 0.41 mg/kg infused over 52 min (K1)
干预措施: Ketamine 0.41 mg/kg (Drug)
K2
Ketamine 0.71 mg/kg infused over 52 min (K2)
干预措施: Ketamine 0.71 mg/kg (Drug)
LZP
Lorazepam 2 mg infused over 52 minutes (LZP)
干预措施: Lorazepam 2 mg (Drug)
结局指标
主要结局
Change in Cue Reactivity
时间窗: Baseline and 24 hours after infusion
Serial visual analogue scale (VAS) scores for craving elicited by cocaine cue: units on a scale (0-200), high is worse. Scores are obtained at baseline and at 24 hours after the infusion.
Change in Motivation to Quit
时间窗: Baseline and 24 hours post-infusion
Motivation score obtained from the University of Rhode Island Change Assessment (URICA). Scores are obtained at baseline and at 24 hours after each infusion. The scores are 0-13, with higher scores indicating greater motivation. The analysis is within-subject. Scores included below are means; higher scores represent higher motivation to quit than do lower scores.
次要结局
未报告次要终点
研究者
Elias Dakwar
Assistant Professor Clinical Psychiatry
New York State Psychiatric Institute