How Does the Opioid System Shape Stress and Social Behaviour in Men and Women and What Role Does Childhood Unpredictability Play?

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSara L. Kroll

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Morphine

    Drug

    Sevredol 10mg, oral single-dose administration

  • Placebo

    Drug

    identical in appearance to active drug, containing no active substance (mannitol), oral one-time administration

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: MorphineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-report of subjective stress during stress exposure

Sex-specific differences in the stress relieving effects of morphine compared to placebo. Subjective stress response will be measured by differences between self- and other condition in ratings using a 1-7 Visual Analogue Scale (VAS) with the anchors "not at all" (1) to "very much" (7) for the items "How secure do you feel?" and "How stressed do you feel?" throughout the stress task.

Time frame
During the experimental stress task
2

Endocrinological markers of stress response

Sex-specific differences in the stress relieving effects of morphine compared to placebo measured by changes in plasma concentrations of cortisol and endocannabinoids (2-AG, AEA, PEA, SEA, OEA).

Time frame
Throughout the experiment sessions (baseline and approx. 10, 20, 30, 60 and 105 minutes after stress onset, 6 samples).
3

Psychophysiological stress response of heart rate measured by electrocardiogram

Sex-specific differences in the stress relieving effects of morphine compared to placebo measured by differences between self and other condition in heart rate (beats per minute).

Time frame
During the experimental stress task
4

Psychophysiological stress response of heart rate variability measured by electrocardiogram

Sex-specific differences in the stress relieving effects of morphine compared to placebo measured by differences between self and other condition in heart rate variability.

Time frame
During the experimental stress task

Secondary outcomes

1

Subjective differences in experiencing social interaction

Sex-specific differences in morphine effects on subjective pleasantness ratings measured by VAS scales (1-100) during the social approach/avoidance task and affective touch task with higher ratings indicating more pleasantness.

Time frame
During the experimental tasks
2

Behavioural differences of social approach and avoidance

Sex-specific differences in morphine effects on behavioural measures (measured by number of button presses) during the social approach/avoidance task.

Time frame
During the experimental task
3

Psychophysiological cardiac markers of social interaction measured by heart rate using electrocardiogram

Sex-specific differences in morphine effects on heart rate (beats per minute) during the social approach/avoidance task and the affective touch task.

Time frame
During the experimental tasks
4

Psychophysiological cardiac markers of social interaction measured by heart rate variability using electrocardiogram

Sex-specific differences in morphine effects on heart rate variability during the social approach/avoidance task and the affective touch task.

Time frame
During the experimental tasks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sara L. Kroll

Lead sponsor

Psychiatric University Hospital, Zurich

Sponsor institution