NL-OMON21224已完成不适用
The effects of endocannabinoid system deficits induced by early-life stress on fear memory extinction
Radboudumc, Nijmegen0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •In each substudy, in order to be eligible to participate in this study, a participant must meet all of the following criteria:
- •For both groups:
- •?Healthy volunteers between 18 and 45 years of age.
- •?For substudy 2 only: History of taking cannabis.
- •For ELS group:
- •?Meet the criteria for ELS as measured using the self-report questionnaire Maltreatment and Abuse Chronology of Exposure Scale (MACE-X)”. There are 10 subscales in MACE-X, the criterion for each subscale is listed below.
- •?In the emotional neglect subscale, the cut-off is 2 items out of 5.
- •?In the parental non-verbal abuse subscale, the cut-off is 4 out of 6.
- •?In the parental physical maltreatment subscale, the cut-off is 4 items.
- •?In the parental verbal abuse subscale, the cut-off is 3 items out of 4.
- •?In the sexual abuse subscale, the cut-off is 2 items out of 7.
- •?In the witnessing interparental violence subscale, the cut-off is 2 items out of 5.
- •?In the peer verbal abuse subscale, the cut-off is 4 items out of 5.
- •?In the peer physical bullying subscale, the cut-off is 2 items out of 5.
- •?In the physical neglect, the cut-off is 2 items out of 5.
- •?In the witnessing violence to siblings subscale, the cut-off is 1 items out of 4.
- •We will include people a) who meet the criterion on any single subscale, while only counting items under age of ten, or b) who meet the criteria on multiple subscales regardless of age, when the sum of percentages of the cut-offs reached below the age of ten for each of these subscales equals or exceeds 100. For instance, if a potential participant scores 2 item on the sexual abuse subscale, of which 1 is below the age of 10, and scores 5 on the verbal abuse subscale, of which 3 are below the age of ten, then this participant would be included because (1/2) *100 + (3/4) *100 = 125.
- •?For Non-ELS group: We aim to recruit participants in the control group with no experiences of ELS. The MACE-X has six subscales which are indicate severe childhood maltreatment: Emotional Neglect, Parental Nonverbal Emotional Abuse, Parental Physical Maltreatment, Parental Verbal Abuse, Sexual Abuse, or Witnessing Interparental Violence. The criterion for each of these subscales is listed below.
- •?In the emotional neglect subscale, the cut-off is 2 items out of 5.
- •?In the parental non-verbal abuse subscale, the cut-off is 4 out of 6.
- •?In the parental physical maltreatment subscale, the cut-off is 4 items.
- •?In the parental verbal abuse subscale, the cut-off is 3 items out of 4.
- •?In the sexual abuse subscale, the cut-off is 2 items out of 7.
- •?In the witnessing interparental violence subscale, the cut-off is 2 items out of 5.
- •And four subscales which are less relevant to severe childhood maltreatment. The criterion for each of these subscales is listed below.
- •?In the peer verbal abuse subscale, the cut-off is 4 items out of 5.
- •?In the peer physical bullying subscale, the cut-off is 2 items out of 5.
- •?In the physical neglect, the cut-off is 2 items out of 5.
- •?In the witnessing violence to siblings subscale, the cut-off is 1 items out of 4
- •We will include people into the control group who a) score 0 on the six subscales most relevant to severe childhood maltreatment (SCM) listed above, and b) score below the cut-off on the other four subscales less relevant to severe childhood maltreatment, and c) do not score any item on these four subscales below the age of ten.
排除标准
- •In each study, a potential subject who meets any of the following criteria will be excluded from participation in this study:
- •For both groups:
- •?Body mass index lower than 18.5 or higher than 30.
- •?Abnormal hearing or (uncorrected) vision.
- •?Average use of psychotropic medication or recreational drugs weekly or more.
- •?Habitual smoking, i.e. more than a package of cigarettes per week and a self-reported
- •inability or unease to cease smoking for 24 hours prior to testing.
- •?Use of psychotropic medication, or of recreational drugs over a period of one week prior to each test session, and use of alcohol within the last 24 hours before each measurement.
- •?Regular use of corticosteroids.
- •?Current psychiatric treatment. (e.g., severe depression, anorexia nervosa, severe mood disorders, mania, schizophrenia or borderline personality disorder)
- •?Current neurological treatment.
- •?Current endocrine treatment. (e.g., phechromocytoma, hyperthyroidism, Cushing’s syndrome)
- •?Contraindication for systemic hydrocortisone (e.g., ulcus ventriculi, ulcus duodeni, certain infections, and eye problems that point toward a risk (closed-angle) glaucoma).
- •?History of repeated (more than once) of autonomic failure (e.g., vasovagal reflex syncope).
- •?Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, deep brain stimulation, claustrophobia)
- •?Metal objects in or around the body (braces, pacemaker, metal fragments, hearing devices).
- •?Use of medication that may interact with hydrocortisone (study 1) or THC (study 2). E.g., for Hydrocortisone, e.g., taking taking mifepristone within one week before and during the study period is reason for exclusion. For THC, taking rifampicin, ketoconazole, and omeprazole will not be allowed within one week before and during the study period.
- •?Cognitive impairment (MMSE < 26)
- •?Night shift work
- •?Known enhanced risk of using THC or hydrocortisone
研究者
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