SFB TRR 265: Losing and Regaining Control Over Drug Intake Work Package 1 of Project B03: General and Specific Pavlovian-to-Instrumental Transfer Effects in a Range of Substance Use Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Neural PIT effect
研究概览
简要总结
During the first funding period (1st FP), the investigators developed a novel full Pavlovian-to-instrumental transfer (PIT) task that allows assessing both, general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, the investigators want to compare specific and general PIT effects in patients with moderate to severe substance use disorders (alcohol, cannabis, methamphetamine, amphetamine and cocaine) to healthy controls on the behavioral and neural level (fMRI).
详细描述
This projects research aim:
- The investigators aim to compare general and specific PIT effects in patients with moderate to severe substance use disorder (Alcohol, Methamphetamine, Amphetamine and Cocaine) and healthy controls using the newly developed (1st FP) full transfer task and fMRI The investigators expect enhanced general PIT effects in patients compared to controls at the behavioral level, and at the neuronal level enhanced PIT-associated activations in the striatum, and lower activation in the prefrontal cortex (e.g., dlPFC).
The investigators expect enhanced general PIT effects in patients with multiple SUD compared to patients with single SUD.
The investigators expect increased behavioral and neuronal alcohol-specific PIT effects in patients groups that also meet AUD criteria compared to controls and to patients without AUD.
The investigators expect stronger behavioral and neural PIT effects (both general and specific) to predict more substance use at 3-month follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 否
入选标准
- •Men and women between 18-65 years of age,
- •AUD, and/or SUD subjects only: meet 4 or more criteria for DSM-5 alcohol-related and/or substance-related (cannabis, amphetamine, methamphetamine or cocaine disorder (not requiring withdrawal as assessed by an independent psychiatrist),
- •Currently using alcohol without a desire for abstinence
- •Ability to consent to the study and complete the questionnaires.
- •Sufficient language(German) and motor skills for using PC
- •existing health insurance
排除标准
- •Lifetime diagnosis of DSM-5 bipolar disorder or schizophrenia or schizophrenia spectrum disorder (if induced by drugs, it should happen more than a month ago)
- •Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
- •High risk (≤ 26) ASSIST scores in other substances other than alcohol, amphetamine, methamphetamine, cannabis, cocaine, tobacco
- •History of traumatic brain injury or severe neurological disease (such as Dementia, Parkinson's disease, multiple sclerosis, Epilepsy, Meningitis, Stroke)
- •Pregnancy or breastfeeding,
- •Ingestion of medications known to interact with the dopamine system in the 10-day period prior to study participation or less than 4 half-lives after last ingestion (rapid urine test); A detailed list of permitted medication can be added upon request
- •MR contraindications (e.g., pacemakers, metallic or electronic implants, metallic splinters, surgical staples)
- •Color vision deficiency
- •sensorineural hearing loss of 30 dB or greater,
- •Tinnitus and
- •Acute alcohol, substance (cannabis, or methamphetamine, amphetamine, cocaine) intoxication at assessement day verified by breath alcohol tests and drug intoxication verified by rapid urine test.
研究组 & 干预措施
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
干预措施: fMRI imaging (BOLD) (Biological)
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
干预措施: sMRI (structure) (Biological)
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
干预措施: Pavlovian-to-instrumental transfer (PIT) paradigm (Behavioral)
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
干预措施: Basic psychological assessment (interview) (Diagnostic Test)
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
干预措施: Basic psychological assessment (questionnaires) (Diagnostic Test)
Alcohol use disorder (AUD)
Participants with alcohol use disorder (moderate to severe if no withdrawal symptoms) and no other substance use disorder (SUD)
干预措施: Neuropsychological tests (Behavioral)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:
Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
干预措施: fMRI imaging (BOLD) (Biological)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:
Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
干预措施: sMRI (structure) (Biological)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:
Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
干预措施: Pavlovian-to-instrumental transfer (PIT) paradigm (Behavioral)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:
Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
干预措施: Basic psychological assessment (interview) (Diagnostic Test)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:
Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
干预措施: Basic psychological assessment (questionnaires) (Diagnostic Test)
Alcohol use disorder (AUD) and Substance use disorder (SUD)
Participants with Alcohol use disorder (AUD) and comorbid Substance use disorder (SUD) (moderate to severe cases without withdrawal symptoms) including:
Participants with alcohol use disorder (AUD) and/or cannabis use disorder and/or methamphetamine use disorder and/or amphetamine use disorder and/or cocaine use disorder.
干预措施: Neuropsychological tests (Behavioral)
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:
Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
干预措施: fMRI imaging (BOLD) (Biological)
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:
Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
干预措施: sMRI (structure) (Biological)
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:
Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
干预措施: Pavlovian-to-instrumental transfer (PIT) paradigm (Behavioral)
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:
Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
干预措施: Basic psychological assessment (interview) (Diagnostic Test)
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:
Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
干预措施: Basic psychological assessment (questionnaires) (Diagnostic Test)
Non-AUD Substance use disorder (SUD)
Participants with substance use disorder (moderate to severe cases without withdrawal symptoms) without alcohol use disorder (AUD) including:
Participants with methamphetamine use disorder and/or cannabis use disorder and/or amphetamine use disorder and/or cocaine use disorder
干预措施: Neuropsychological tests (Behavioral)
Control group
Healthy participants without AUD or SUD
干预措施: fMRI imaging (BOLD) (Biological)
Control group
Healthy participants without AUD or SUD
干预措施: sMRI (structure) (Biological)
Control group
Healthy participants without AUD or SUD
干预措施: Pavlovian-to-instrumental transfer (PIT) paradigm (Behavioral)
Control group
Healthy participants without AUD or SUD
干预措施: Basic psychological assessment (interview) (Diagnostic Test)
Control group
Healthy participants without AUD or SUD
干预措施: Basic psychological assessment (questionnaires) (Diagnostic Test)
Control group
Healthy participants without AUD or SUD
干预措施: Neuropsychological tests (Behavioral)
结局指标
主要结局
Neural PIT effect
时间窗: 1 day
Blood oxygenation level dependent (BOLD) response, investigation of neuronal activation of the mesolimbic system in AUD patients and controls using 3 Tesla magnetic resonance imaging
Behavioral full-lever specific and general PIT effect
时间窗: 1 day
Strength of specific and general PIT effect assessed with the full-lever PIT paradigm. Specific: average percentage of alcohol choice difference during the presentation of alcohol or non-alcohol Pavlovian background. General: differences in number of button presses during the presentation of positive (+10 Euro) and negative (-10 Euro) Pavlovian backgrounds.
次要结局
- Alcohol and Substance (cannabis, stimulant/cocaine) consumption after 3 months(3 months after testing for behavioral and neural PIT effects)