NCT07778511 How Does the Opioid System Shape Stress and Social Behaviour in Men and Women and What Role Does Childhood Unpredictability Play?
| NCT ID | NCT07778511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sara L. Kroll |
| Condition | Stress |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-09-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2026-09-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study aims to investigate sex differences in the effect of mu-opioid receptor (MOR) activation on stress response and social behaviour modulated by early life stress.
Eligibility Criteria
Inclusion Criteria: * Age 18-40 years * Ability to read, understand, and provide written informed consent in German * Proficiency in German * Able to give blood samples (no blood- or needle-related phobia) * Good health as determined by medical history, ECG, and clinical assessment of lab tests. Lab tests will include potassium, creatinine, hemoglobin, glucose, calcium, BUN, complete blood count, total bilirubin, AST, ALT, and GGT. The final decision will be according to the judgment of the study physician. * Females must have a negative urine pregnancy test (hCG) at inclusion and at the start of each study session. Females of childbearing potential who are sexually active and have not been surgically sterilized must agree to use an adequate method of birth control during the study. * Prior experience with medical opioids (at least one experience with prescription opioids such as oxycodone, morphine, hydromorphone, fentanyl, hydrocodone, codeine, or dihydrocodeine) and paracetamol. * Body mass index (BMI) between 19 and 30 kg/m2 Exclusion Criteria: * Any current instable medical or neurological condition * Any clinically significant psychiatric disorder (i.e., psychotic and stress-related disorders) including a diagnosis of substance use disorder (defined in DSM-5 terms as Moderate or Severe). Participants will be screened using the Structured Clinical Interview - SCID for DSM-5). If indication is obtained that a clinically significant psychiatric disorder may be present, a full SCID will be carried out by appropriately trained staff. * Significant adverse reaction to prior opioid or paracetamol exposure * Reporting any illegal drug use \>15 life-time occasions and regular drug use during the last three months incl. the test period (except for nicotine and alcohol) * Any current use of CNS-active medications. * Current use of opioid analgesics, opioid use for \> 6 weeks (lifetime), or within the three months prior to study enrollment. * Fagerström Test of Nicotine Dependence (FTND) Score \> 5 (strong nicotine dependence) * Heavy alcohol use based on the Alcohol Use Disorder Identification Test (AUDIT) * Lifetime diagnosis of cardiac disease. * Clinically significant laboratory or ECG abnormality that could be a safety issue in the study * Acute or chronic respiratory issues (e.g., cold, flu, asthma, etc.) * Lifetime diagnosis of liver or kidney disease including moderate or severe renal impairment (creatinine clearance \< 50 ml/min) * Lifetime diagnosis of schizophrenia, bipolar disorder, obsessive-compulsive disorder, or autism spectrum disorder according to DSM-5 * Diagnosis of a current episode of depression based on DSM-5 criteria * Current diagnosis of a moderate or severe substance use disorder according to DSM-5 * Daily cannabis consumption in the past three months * Use of psychotropic medication within the last 7 days * Participation in other pharmacological studies within the last 2 months * Alcohol use within the last 24 hours controlled by breathalyzer * Unable to provide a negative urine drug screen (cannabinoids, amphetamines, opiates and opioids, benzodiazepines, and cocaine). * Positive pregnancy test or nursing (self-report) * For women: irregular menstrual cycle or menopause
Contact & Investigator
Sara L Kroll, Dr.
PRINCIPAL INVESTIGATOR
Psychiatric University Hospital, Zurich
Frequently Asked Questions
Who can join the NCT07778511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Stress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07778511 currently recruiting?
Yes, NCT07778511 is actively recruiting participants. Contact the research team at saraliane.kroll@bli.uzh.ch for enrollment information.
Where is the NCT07778511 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT07778511 clinical trial?
NCT07778511 is sponsored by Sara L. Kroll. The principal investigator is Sara L Kroll, Dr. at Psychiatric University Hospital, Zurich. The trial plans to enroll 72 participants.