Neuroimaging Response Inhibition and Salience Attribution Changes During Mindfulness-based Treatment of Human Heroin Addiction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Change in fMRI BOLD signal acquired during resting-state functional connectivity
研究概览
简要总结
In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will be assessed before, immediately and three months after treatment. Results could point to factors that track and predict recovery with treatment, offering clinicians markers that can be used for enhancing precision medicine with the goal of reducing morbidity and mortality associated with opiate addiction.
详细描述
Over the past 15 years, the US has been affected by increasing prescription and illicit opiate/opioid abuse, addiction, and overdose. Research into the enhancement of treatment options for individuals with opiate/opioid use disorder (iOUD) is clearly a priority. The development of neuroscience-informed behavioral therapies that could be used as adjuncts to improve effectiveness of medication-assisted interventions in iOUD is a national priority, a response to the opiate crisis. This study measures the neural correlates of cognitive function and reward processing as potentially contributing to and predictive of the impact of an 8-week group therapy on addiction outcome in iOUD. Using a pre-post randomized treatment design with a 3-months follow-up, this study will examine the impact of group therapy, as add-on to methadone maintenance, on neural functional and structural plasticity, and clinical outcomes (including daily ecological momentary assessments), in treatment-seeking iOUD (with primary use of heroin). Treatment-seeking iOUD will be randomized to 8-weeks of one of two of group therapies and scanned with magnetic resonance imaging (MRI) immediately before and after treatment. Healthy controls will be scanned at similar time intervals. Clinical outcome will be assessed during, immediately after and 3-months after therapy. Results may help identify individual variability in the brain regions/circuits that support reward processing, including cue reactivity, and inhibitory control and that could change with, and predict, response to treatment, ultimately contributing to precision medicine in OUD.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The PI and the majority of study personnel, including the study statistician, will be blinded to the treatment assignment until the database is unlocked. Assessors (of endpoints) will also be blinded to treatment assignment. That is, treatment allocation will only be known by selected research associates who are not involved in assessment or treatment. The selected research associates who are unblinded will handle randomization and preparation of any unblinded reports (if required); they will not have access to the data and no involvement in data monitoring or analyses.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to understand and give informed consent
- •Males and Females 18-64 years of age
- •DSM-5 diagnosis of OUD with heroin as the primary drug of choice
- •Stabilized on methadone or other form of MAT.
- •Inclusion criteria for healthy controls:
- •- The same as inclusion criteria 1-2 above; dependence on nicotine or caffeine is non-exclusionary.
排除标准
- •DSM-5 diagnosis for schizophrenia or developmental disorder (e.g., autism)
- •Head trauma with loss of consciousness
- •History of neurological disease of central origin including seizures
- •Cardiovascular disease including high blood pressure and/or other medical conditions, including metabolic, endocrinological,oncological or autoimmune diseases, and infectious diseases common in iOUD including Hepatitis B and C or HIV/AIDS
- •Metal implants or other MR contraindications
- •Exclusion criteria for healthy control subjects:
- •- The same, except history of any drug use disorder is prohibitive.
研究组 & 干预措施
Behavioral group therapy 1
8-weeks of group therapy
干预措施: Behavioral group therapy #1 (Behavioral)
Behavioral group therapy 2
8-weeks of group therapy
干预措施: Behavioral group therapy #2 (Behavioral)
结局指标
主要结局
Change in fMRI BOLD signal acquired during resting-state functional connectivity
时间窗: baseline and 3 months after treatment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during resting-state functional connectivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. This method captures the synchronicity of low-frequency, spontaneous fluctuations in blood oxygen level-dependent signals that reflect fluctuations in neuronal activity between brain regions in the absence of external stimulation.
Change in fMRI BOLD signal during tasks of reward
时间窗: baseline and 3 months after enrollment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during tasks of reward at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. The reward task uses symbols of gain/win and has been shown to elicit BOLD activations in the brain's reward network.
Change in Urine drug test
时间窗: baseline and 3 months after treatment
Urine drug test at 3 months after treatment as compared to baseline
Change in fMRI BOLD signal for control reactivity
时间窗: baseline and 3 months enrollment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during control reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Change in fMRI BOLD signal for cue reactivity
时间窗: baseline and 3 months enrollment
Change in fMRI blood-oxygen-level dependent (BOLD) signal acquired during cue reactivity at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI.
Change in MRI Voxel-Based Morphometry (VBM) measure
时间窗: baseline and 3 months after treatment
Change in MRI VBM measure for grey matter volume at the 2nd MRI conducted immediately after the 8-week group therapy (about 3 months after enrollment) as compared to baseline MRI. Voxel Based Morphometry is a whole-brain, fully automated, unbiased, MRI analysis technique used to detect regionally specific differences in brain tissue composition using a voxel-wise comparison across participants.
次要结局
未报告次要终点
研究者
Rita Goldstein
Professor of Psychiatry and Neuroscience
Icahn School of Medicine at Mount Sinai