NL-OMON50765已完成2 期
Early-life stress, the endocannabinoid system, and fear memory extinction - Early-life stress, the endocannabinoid system, and fear memory extinction
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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.
- •* Predominant right-handedness.
- •* 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
- •* 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
- •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
- •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
- •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 o
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)
- •* Pregnancy
- •* Night shift work
- •* Known enhanced risk of using THC or hydrocortisone
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