Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Successful Naltrexone Initiation
研究概览
简要总结
Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal.
N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal.
The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active opioid dependence, with at least one positive utox result; no history of opioid overdose; and not currently using methadone or buprenorphine
- •Physically healthy
- •No adverse reactions to study medications
- •21-60 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 >
- •Physiological dependence on another substance requiring medical management, such as alcohol or benzodiazepines, excluding caffeine, nicotine, and cannabis
- •Pregnant or interested in becoming pregnant
- •Delirium, Dementia, Amnesia, Cognitive Disorders, or dissociative disorders
- •Current suicide risk or a history of suicide attempt within the past 2 years
- •On psychotropic or other medication whose effect could be disrupted by participation in the study
- •Recent history of significant violence (past 2 years).
- •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 (transaminase levels < 2 X the upper limit of normal will be considered acceptable), or untreated diabetes
- •Previous history of CI-581 abuse, and/or a history of adverse reaction/experience wtih prior exposure to CI-581 or benzodiazepines
- •BMI > 35, or a history of unmanaged obstructive sleep apnea
- •First degree relative with a psychotic disorder (bipolar disorder with psychotic features, schizophrenia, schizoaffective disorder, or psychosis NOS)
- •History of opioid overdose over the past 2 years requiring medical intervention
- •Currently using methadone or buprenorphine
研究组 & 干预措施
CI-581aa
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
干预措施: CI-581aa (Drug)
CI-581aa
CI-581aa will be administered 24 hours after last opioid use, and followed by naltrexone dosing
干预措施: Naltrexone titration and XR-NTX initiation (Drug)
结局指标
主要结局
Successful Naltrexone Initiation
时间窗: 2 weeks
The proportion of participants enrolled in the trial and receiving the infusion to receive XR-NTX
次要结局
- Withdrawal: Subjective Opioid Withdrawal Scale (SOWS) Scores at Baseline and Administered Subsequently(4 days)
研究者
Elias Dakwar
Assistant Professor of Clinical Psychiatry
New York State Psychiatric Institute