Targeting Neural, Behavioral and Pharmacological Mechanisms of Drug Memories in Drug Addiction With Methylphenidate
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- fMRI blood-oxygenation level dependent (BOLD) signal
研究概览
简要总结
This study aims to identify the neural, behavioral, and pharmacological mechanisms promoting diminished expression of drug-related memories in human drug addiction. In this fMRI study with a within-subjects placebo-controlled double-blind cross-over design, oral methylphenidate (20 mg) or placebo will be administered to individuals with cocaine use disorders (CUD) to peak during the retrieval of a drug-cue memory before extinction; in addition to fMRI activations, skin conductance responses (SCR, acquired simultaneously) will serve as the psychophysiological indicators of memory modification. Assessments of interference with the return of drug-cue memories via SCR and craving will be conducted the day following MRI. This pharmocologically-enhanced behavioral approach to decreasing drug memories and craving in iCUD could ultimately be used to develop effective cue-exposure therapies for drug addiction. Procedures include MRI, blood draw, questionnaires and interviews, skin conductance response measures, and behavioral tasks.
详细描述
Cue-exposure therapy has not proven efficacious in reducing relapse in drug addiction, illuminating the need for alternative strategies. Here researchers will test the neural correlates of two strategies, encompassing behavioral and pharmacological approaches, aimed to interfere with the return of drug memories in individuals with cocaine use disorders. Results may pave the way towards enhancing the efficacy of cue-exposure therapy in reducing cue-induced craving and relapse in drug addiction (generalizable across drugs of abuse/behavioral addictions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 26 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and give informed consent
- •Males and females, 18-65 years of age
- •DSM-V diagnosis for CUD or otherwise problematic cocaine use as clinically determined
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 including Hepatitis B and C or HIV/AIDS
- •Metal implants or other MR contraindications
研究组 & 干预措施
Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
干预措施: Methylphenidate (Drug)
Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
干预措施: Methylphenidate (Drug)
Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
干预措施: Placebo (Drug)
Placebo then Methylphenidate
Matching placebo pill then 20 mg of methylphenidate.
干预措施: Memory reconsolidation (Behavioral)
Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
干预措施: Memory reconsolidation (Behavioral)
Methylphenidate then Placebo
20 mg of methylphenidate then matching placebo pill.
干预措施: Placebo (Drug)
结局指标
主要结局
fMRI blood-oxygenation level dependent (BOLD) signal
时间窗: Day 7
fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.
fMRI blood-oxygenation level dependent (BOLD) signal
时间窗: Day 1
fMRI blood-oxygenation level dependent (BOLD) signal deactivation in the ventromedial prefrontal cortex in response to retrieval of drug-cue memory.
次要结局
- Skin Conductance Responses (SCR)(24 hours after each neuroimaging session)
- Craving(24 hours after each neuroimaging session)
研究者
Rita Goldstein
Chief of Research
Icahn School of Medicine at Mount Sinai