Glutamatergic Modulation to Facilitate the Behavioral Treatment of Cocaine Use Disorders
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Abstinence from Cocaine Use
研究概览
简要总结
Changes in the communication of glutamate from one brain structure to another are important in the development of therapy for cocaine use disorders. Our preliminary investigations suggest that drugs that affect glutamate exchange may be effective at promoting and maintaining individuals' abstinence from cocaine. The purpose of this randomized, double-blind, controlled trial is to test various glutamate modulators in conjunction with motivational enhancement therapy (MET) and mindfulness based relapse prevention (MBRP) for cocaine use disorders.
详细描述
Alterations in the transmission between neurons of a neurotransmitter called glutamate are an important target of pharmacotherapy for cocaine use disorders (CUDs). Preliminary investigations suggest that glutamate modulation may be effective at promoting and maintaining abstinence and that it promotes motivation to quit, reduces craving, reduces cocaine self-administration and facilitates abstinence in individuals with a CUD in a series of trials.
The study team has recently developed and tested a novel design that integrates a clinical trial involving serial infusions and a behavioral treatment platform. The current trial will evaluate the effect of two sub-anesthetic infusions on abstinence rates in a relatively large sample of treatment-seeking CUD individuals who complete a 12-week double-blind, randomized, controlled trial. It will also evaluate the correlation between clinical response and brain-derived neurotrophic factor (BDNF), a peripheral biomarker relevant to glutamate modulation antidepressant response. This project aims to expand on several years of promising preliminary data to rigorously evaluate the efficacy of this innovative pharmacological intervention integrated into a behavioral treatment platform.
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)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets DSM-V criteria for cocaine use disorders, with at least 1 day of use per week for three weeks over the past month
- •Physically healthy
- •No adverse reactions to study medications
- •18-70 years of age
- •Capacity to consent and comply with study procedures
- •Seeking Treatment
排除标准
- •Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, any psychotic illness, including substance-induced psychosis, and current substance-induced mood disorder with HAMD score >
- •Physiological dependence on another substance, such as alcohol, opioids, or benzodiazepines, excluding caffeine and nicotine, requiring imminent medical management
- •Delirium, dementia, amnesia, cognitive disorders, or dissociative disorders
- •Current suicide risk or a history of suicide attempt within the 2 years
- •Pregnant, interested in becoming pregnant, or lactating
- •On psychotropic or other medication whose effect could be disrupted by participation in the study, such as benzodiazepines, opioids, or barbiturates
- •Recent history of significant violence
- •Heart disease as indicated by history, abnormal ECG, previous cardiac surgery.
- •Unstable physical disorders which might make participation hazardous such as hypertension (>160/90), anemia, active hepatitis or other liver disease (transaminase levels < 2-3 X the upper limit of normal will be considered acceptable), or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis
- •Previous history of a substance use disorder with the study medications or benzodiazepine abuse and/or a history of adverse reaction/ experience with prior exposure to study medications or benzodiazepines
研究组 & 干预措施
CI-581a+MET+MBRP
Administration of CI-581a at 0.71 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
干预措施: CI-581a (Drug)
CI-581a+MET+MBRP
Administration of CI-581a at 0.71 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
干预措施: Motivational Enhancement Therapy (MET) (Behavioral)
CI-581a+MET+MBRP
Administration of CI-581a at 0.71 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
干预措施: Mindfulness Based Relapse Prevention (Behavioral)
CI-581b+MET+MBRP
Administration of CI-581b at 0.025 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
干预措施: CI-581b (Drug)
CI-581b+MET+MBRP
Administration of CI-581b at 0.025 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
干预措施: Motivational Enhancement Therapy (MET) (Behavioral)
CI-581b+MET+MBRP
Administration of CI-581b at 0.025 mg/kg during weeks 1 and 5 combined with a 12-week course in MET and MBRP
干预措施: Mindfulness Based Relapse Prevention (Behavioral)
结局指标
主要结局
Abstinence from Cocaine Use
时间窗: from baseline to week 12
次要结局
未报告次要终点
研究者
Elias Dakwar
research psychiatrist
New York State Psychiatric Institute