Brain Mechanisms of Cognitive Response to Pharmacotherapy in Opioid Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- fMRI Signal
研究概览
简要总结
This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neural circuits underlying key cognition functions. The study will use previously validated cognitive probes, functional Magnetic Resonance Imaging (fMRI), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in OUD patients to explain the individual heterogeneity of OUD treatment response.
详细描述
This proposal seeks to identify the neural circuits underlying the cognitive effects of medication assisted therapy (MAT) for OUD. The study will examine the neurocognitive effects of MAT by comparing two preparations with different pharmacodynamic properties (extended release buprenorphine and naltrexone, XRBUP, XRNTX) in three key domains (incentive salience, executive functioning, and emotion processing) using task functional Magnetic Resonance Imaging (MRI). In the 1st phase of the study, forty treatment-seeking OUD patients will be randomized to XRNTX or XRBUP groups after detoxification. Participants will undergo medication induction followed by monthly injections and urine toxicology monitoring for 120 days. Neuroimaging will follow completion of detoxification (pre-treatment) and 15 days after the second injection (on-treatment). The second study phase will extend the paradigm to an independent sample of 160 additional participants and test the explanatory value of MAT-induced changes in the neuroimaging signal in the classification of OUD treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and Females
- •18-65 Years old
- •OUD by DSM5 Criteria, confirmed by history and physical examination including urine toxicology, medical records and self-report
- •Opioids are the drug of choice
- •Interested in injectable extended release agonist or antagonist treatment
- •Have a stable address, working command of English language, and telephone access.
- •Women of childbearing age must use an effective contraceptive
排除标准
- •Psychiatric Co-morbidities:
- •Lifetime diagnoses of any psychotic disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder type
- •Psychiatric Co-morbidities: Psychiatric disorders requiring current medication treatment, e.g. moderate to severe depression. Mild to moderate Depressive and Anxiety disorders and Attention Deficit Hyperactivity Disorder that do not require prescription stimulants and DSM5 Cluster B and C personality disorders are also allowed.
- •Polysubstance users whose drug of choice is not opioids.
- •Contraindications for XRNTX or XRBUP e.g. active liver disease.
- •Medical and surgical conditions such as malignancy that may affect patients' ability to receive XRNTX or XRBUP treatment because it may interfere with opioid analgesia
- •Contraindications for MRI, e.g. claustrophobia, indwelling foreign magnetic agents.
研究组 & 干预措施
Buprenorphine
Participants assigned to treatment with extended-release buprenorphine
干预措施: Brixadi (Drug)
Naltrexone
Participants assigned to treatment with extended-release naltrexone
干预措施: Vivitrol (Drug)
结局指标
主要结局
fMRI Signal
时间窗: up to 90 days
Brain fMRI response to neurocognitive probes
Urine Toxicology: Opioid
时间窗: Through the study completion, up to 120 days
Rapid semi-quantitative ELISA urine drug screen test for morphine, oxycodone and methadone, followed by (cut off levels): Methadone (MTD) Methadone 300 ng/mL Opiates (OPI 300) Morphine Morphine \*\*300 ng/mL Oxycodone (OXY) Oxycodone 100 ng/mL
次要结局
- Anxiety(Through the study completion, up to 120 days)
- Depression(Through the study completion, up to 120 days)
- Non-opioid Urine Toxicology(Through the study completion, up to 120 days)