Neural Mechanistic Explanations for Differential Drug Abuse Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The focus of our outcome evaluation will be use of opioid (e.g., frequency, days of continuous abstinence, etc.), coping strategies, and change in lifestyle measures (e.g., employment, relationships, behavioral problems, treatment engagement).
研究概览
简要总结
Background:
Although some treatments for substance abuse are considered effective for some people who are drug dependent, many others do not benefit as much over time. Researchers are working to find out what characteristics predict treatment response. They also want to determine how to design treatments that are more effective for a greater number of substance abusers. This pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a treatment considered to be one of the most effective in reducing substance-abuse, to identify ways in which the brain works that may predict and explain treatment effects. A comparison group will be included that receives only standard psychotherapy or talk therapy. This approach will enable researchers to determine what factors might be interfering with favorable treatment outcomes and how to refine or develop new treatments that work well for more people.
Objectives:
- To identify individual characteristics which predict and explain the effects of CBT in people with opiate dependence.
Eligibility:
- Males between 18 and 60 years of age who are dependent on opioids (such as heroin).
- Participants must be willing to take buprenorphine and receive substance abuse counseling.
Design:
- Participants will be screened with a physical exam and medical history.
- Researchers will ask questions about participants ability to cope in certain situations, along with questions about drug use and lifestyle issues. These questions will be asked twice, before and after completing treatment.
- Participants will be placed into one of two groups. One group will have CBT twice a week for 8 weeks. The other group will have standard counseling twice per week. Both groups will take buprenorphine as part of the drug abuse treatment.
- Participants will have other tests during this study. They will have imaging studies to look at brain function. These studies will test thinking and decision making.
详细描述
OBJECTIVE:
The primary objective of this pilot study is to collect data for a NIH RO1 grant submission that aims to elucidate cognitive, emotional regulatory and neurobiological mechanisms that both moderate and mediate effects of cognitive behavioral therapy (CBT) in individuals with opiate dependence. CBT has proven moderately effective in treating substance abuse; however, significant variability in treatment outcomes remains. CBT curricula teach adaptive decision making and cognitive reappraisal skills to down-regulate emotional responses to drug-related cues, thereby promoting avoidance of drug use situations. A certain level of cognitive and emotion regulatory functioning is, however, required for assimilating and executing these skills which is often deficient in substance abusers. Consequently, many addicts cannot effectively process and act on CBT curriculum, leading to poor treatment outcomes. Tailoring interventions requires systematic investigation of neurobiological indicators that interfere with or promote favorable treatment responsivity.
The small pilot study outlined below will provide the feasibility and supportive data for a larger effort.
Aim 1: Moderation. Identify baseline ECF and emotion regulatory functions and their neural substrates that predict treatment variability in the form of: (a) program responsivity (e.g., treatment engagement, motivation, social competences) and (b) posttreatment outcomes (e.g., substance use frequency, days of continuous abstinence). Functional magnetic resonance imaging (fMRI) will be used during performance of tasks that measure ECF (decision-making; inhibitory control) and cognitive reappraisal of emotional cues to investigate the neuromodulatory role of PFC regions (e.g., OFC, ACC) on emotion (e.g., amygdala) and reward (e.g., ventral striatum) structures and autonomic activity.
Aim 2: Mediation. Determine whether change in these neurocognitive functions in response to CBT mediate intervention effects. Evidence suggests that CBT alters PFC and limbic function; such changes are associated with clinical outcomes in depression and anxiety. Similarly, in drug abusers, we predict treatment response will be associated with changes in neural activation patterns, ECF, and emotional regulation, and that little to no change will occur in those with relatively poorer outcomes.
研究设计
- 研究类型
- Observational
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The focus of our outcome evaluation will be use of opioid (e.g., frequency, days of continuous abstinence, etc.), coping strategies, and change in lifestyle measures (e.g., employment, relationships, behavioral problems, treatment engagement).
次要结局
未报告次要终点