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Early-life stress, the endocannabinoid system, and fear memory extinction

Early-life stress, the endocannabinoid system, and fear memory extinction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23960
Enrollment
48
Registered
2017-11-30
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

posttraumatic stress disorder

Interventions

To investigate the role of the endocannabinoid system in fear memory extinction and stress adaption, we will use established behavioral and neuroimaging paradigms including (1) a classical fear condit

Sponsors

Radboudumc
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For both groups: „Ï Healthy volunteers between 18 and 45 years of age. „Ï Predominant right-handedness. „Ï History of taking cannabis. For ELS group: „Ï Comply the inclusion standard with questionnaires: ¡§Maltreatment and Abuse Chronology of Exposure Scale (MACE-X)¡¨. There are 10 subscales in MACE-X, the criterion for each subscale is listed here, all types of exposure of trauma should be before ten years old. There are six subscales which are very relevant to severe childhood maltreatment: Emotional Neglect, Parental Nonverbal Emotional Abuse, Parental Physical Maltreatment, Parental Verbal Abuse, Sexual Abuse, or Witnessing Interparental Violence. Participant should reach at least one criterion of those six subscales to be included for certain types of childhood maltreatment: „X In emotional neglect subscale, ( the cut-off is 2 items out of 5 ). „X In non-verbal emotional abuse subscale, ( the cut-off is 4 out of 6). „X In parental physical maltreatment subscale, ( the cut-off is 4 items). „X In parental verbal abuse subscale, ( the cut-off is 3 items out of 4). „X In sexual abuse subscale, ( the cut-off is 2 items out of 7). „X In witnessing interparental violence subscale, ( the cut-off is 2 items out of 5). There are four subscales which are less relevant to severe childhood maltreatment, the criterion of each subscale are listed here below, if participants only fulfil the criteria of any one or more of those four subscales, they will not be included in ELS group: „X In peer emotional abuse subscale, ( the cut-off is 4 items out of 5 ). „X In peer physical bullying subscale, ( the cut-off is 2 items out of 5 ). „X In physical neglect, ( the cut-off is 2 items out of 5 ). „X In witnessing violence to siblings subscale, ( the cut-off is 1 items out of 4 ). For Non-ELS group: Since we need to recruit participants in control group with no experiences of early-life stress, thus we will include people who score 0 on six very relevant to severe childhood maltreatment (SCM) subscales and also below threshold of other four less relevant to severe childhood maltreatment (LSCM) subscales in ¡§Maltreatment and Abuse Chronology of Exposure Scale (MACE-X)¡¨.

Exclusion criteria

Exclusion criteria: For both groups: „Ï Body mass index lower than 18.5 or higher than 30. „Ï Abnormal hearing or (uncorrected) vision. „Ï Average use of psychotropic medication or recreational drugs weekly or more. „Ï 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. „Ï 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. „Ï Regular use of corticosteroids. „Ï History of psychiatric treatment or current psychiatric treatment. (e.g., severe mood disorders, mania, anorexia nervosa, schizophrenia or borderline personality disorder) „Ï History of neurological treatment or current neurological treatment. „Ï History of endocrine treatment or current endocrine treatment. (e.g., pheochromocytoma, hyperthyroidism, Cushing¡¦s syndrome) „Ï History of repeated (more than once) of autonomic failure (e.g., vasovagal reflex syncope). „Ï Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, deep brain stimulation, claustrophobia) „Ï Use of medication that may interact with THC or hydrocortisone, for THC, taking Rifampicin, Ketoconazole, and Omeprazole at this moment; For Hydrocortisone, taking taking mifepristone at this moment. „Ï Cognitive impairment (MMSE < 26) „Ï Pregnancy „Ï Night shift work

Design outcomes

Primary

MeasureTime frame
autonomic nervous system measurement (skin conductance, heart rate, and pupil dilation responses) and subjective scores on 5-point scale to rate the expectancy of the appearance of the unconditioned stimuli (USs) to fear-conditioned stimuli one day after extinction (i.e., safety learning).

Secondary

MeasureTime frame
Neuroimaging data (founctional and structural neuro images), chemical data (in saliva, and in blood),self-report questionnaires

Contacts

Public ContactErno J. Hermans

Radboud University Nijmegen Medical Centre, Department of Cognitive Neuroscience

erno.hermans@donders.ru.nl024-3668290

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)