fMRI Study of a Dual Process Treatment Protocol With Substance Dependent Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery.
研究概览
简要总结
The purpose of this study is to determine whether drug-dependent adults who participate in a dual processing relapse prevention treatment protocol that allows for sensory-based exposure experiences over 10-weeks in outpatient treatment will show significant brain change related to diminished cue reactivity, and greater improvement in self-efficacy, anxiety, somatization, and treatment retention, as compared to the standard care patients in a relapse prevention program.
详细描述
The substance abuse literature consistently shows that negative emotional states and subjective stress are highly predictive of relapse and significantly influence behavioral motivation. From a neurobiological perspective, stress associated with withdrawal and substance abuse experiences stimulates chemical and hormonal changes in the brain creating a protracted hyperaroused state. Further, cognitive control resources (i.e., cognitive coping skills/relapse prevention training) have been shown to exert minimal impact on behavioral decision-making in the presence of intense affective material. Thus, implicit cognitive processes play a significant role in drug use behavior, decreasing self regulation capacities and increasing risk of. Specifically, high levels of stress can compromise prefrontal cortex functioning, with the nucleus accumbens, orbitofrontal cortex and amygdala functional changes related to increased cue reactivity.
Taken together, the current literature strongly suggests that verbally-based therapies may have limited utility as a singular form of treatment in early substance abuse recovery, as the brain may not be functionally ready for executive level processing. Instead, the multidisciplinary substance abuse literature suggests that psychosocial treatment methods need to include a range of learning approaches that allow for visual-sensory processing, in addition to traditional verbal-based processing. Integrated multi-modal interventions are needed to offer opportunities for activation of these different brain regions to facilitate cognitive-affective balance in behavioral decision-making.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Inclusion Criteria:
- •Age < 18 years old
- •Signed informed consent for this study
- •History of chemical dependency
- •Meets Inova CATS Relapse Prevention admission criteria
- •Must have at least 60 days of sobriety prior to admission with documentation of negative drug and alcohol screening
- •Documentation of HIV negative test result (completed in the past year)
- •Willing and able to attend an out-patient drug treatment group for two hours twice a week for 10 weeks
- •Willing to complete study-required evaluations (including assessments, questionnaires, drug/alcohol testing, week 8 qualitative interview)
- •A score < 25 on the MoCA (Montreal Cognitive Assessment)
排除标准
- •History of taking "anti-craving" medication in the past 90 days
- •Other medical illness or florid psychiatric symptoms that would render the participant inappropriate for study participation
- •History of receiving treatment for addictions other than substance use (i.e. food, gambling, sex)
- •Clinical determination of dementia or organic brain syndrome
- •History of major head injury
- •Incapable of consenting for themselves due to cognitive impairment
- •Enrollment in another study that might interfere with analysis of this study
- •Additional Inclusion Criteria for fMRI sub-study:
- •Willing and able to participate in the fMRI arm of the study
- •If of childbearing capacity, must have negative screening urine pregnancy test and be willing to use birth control as specified in the consent document
- •Additional Exclusion Criteria for fMRI sub-study:
- •Left-handed
- •Cardiac pacemakers or other body metals
- •Other criteria identified on the "MRI Screening Form" that would indicate that having an MRI would be unsafe
- •Pregnancy
- •Claustrophobia (for the fMRI testing)
- •Muscular or back problems that would prevent participant from being able to lie in the scanner for 90 minutes
研究组 & 干预措施
Dual Processing
干预措施: Dual Processing (Behavioral)
Relapse Prevention
干预措施: Relapse Prevention (Behavioral)
结局指标
主要结局
fMRI blood-oxygenation-level-dependent (BOLD) signal change as a measure of emotional reactivity related to the visual presentation of drug-imagery.
时间窗: 10 weeks
In a subset of approximately 26 subjects, fMRI technology will be employed to examine brain structure and function change (pre-treatment and post-treatment) in the amygdaloid region, orbitofrontal cortex, in the anterior cingluate cortex (structure implicated in drug cue attention); in medial prefrontal cortex and right dorsolateral prefrontal cortex (associated with effective behavioral decision-making in substance abusers).
次要结局
- Urine specimen toxicology analysis as a measure of treatment retention.(Weekly for 10 weeks)
- Quality of Life Inventory (QOLI) as a measure of the subject's quality of life.(10 weeks)
- Heart rate during MRI scanning as a measure of emotional reactivity related to the visual presentation of drug-imagery.(10 weeks)
- Brief Symptoms Inventory (BSI), as a measure of subjective craving, anxiety, and somatization(10 weeks)
- Hamilton - Depression Inventory (HAM-D) as a measure of depression.(10 weeks)
- Blood Alcohol Level analysis as a measure of treatment retention.(Weekly for 10 weeks)
研究者
Maria Hadjiyane
Senior Director Behavioral Health Adult Ambulatory Services
Inova Health Care Services