The Effects of Social Support and Oxytocin Administration on Physiological Stress Reactivity in Essential Hypertension

NCT01938911 | Terminated DMC

• 1 other identifier: 215/10
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To test a psychopharmacological intervention strategy which may provide new insights into the mechanisms underlying the physiological hyperreactivity to stress observed in hypertension, we plan to test the effects of the neuropeptide oxytocin and social support on the neurobiological and psychological responsiveness to social stress. The study population for this project consists of 80 hypertensive and 80 normotensive non-smoking medication-free men. We expect exogenous oxytocin administration to enable hypertensives to effectively take advantage of the provided social support. Thereby, oxytocin may enhance the effect of social support on reducing the previously observed physiological hyperreactivity to stress in essential hypertensives.

Conditions

Essential Hypertension

Keywords

Trier social stress test; Oxytocin; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in lipids from baseline

  At 110 minutes

Secondary Outcomes (4)

• Change in lipids from baseline

  At 45, 80, 120, 130, and 170 minutes

• Change in catecholamines from baseline

  At 45, 80, 110, 120, 130, 140, 155, and 170 minutes

• Change in cortisol from baseline

  At 45, 80, 110, 120, 130, 140, 155, 170, 200, and 230 minutes

• Change in cytokine level from baseline

  At 45, 80, 110, 120, 200, and 230 minutes

Study Arms (8)

Hypertensives with oxytocin and social support

EXPERIMENTAL

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Syntocinon-Spray; Behavioral: Social support

Hypertensives with oxytocin without social support

EXPERIMENTAL

80 normotensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Syntocinon-Spray

Hypertensives without oxytocin with social support

EXPERIMENTAL

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Placebo of syntocinon; Behavioral: Social support

Hypertensives without oxytocin or social support

PLACEBO COMPARATOR

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Placebo of syntocinon

Normotensives with oxytocin and social support

EXPERIMENTAL

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Syntocinon-Spray; Behavioral: Social support

Normotensives with oxytocin without social support

EXPERIMENTAL

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Syntocinon-Spray

Normotensives without oxytocin with social support

EXPERIMENTAL

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Placebo of syntocinon; Behavioral: Social support

Normotensives without oxytocin or social support

PLACEBO COMPARATOR

80 hypertensive non-smoking medication-free men will be randomly assigned to receive intranasal OT (24 IU) or placebo 50 min before stress, and either social support (SS) from their best friend during the preparation period of the stress protocol or no social support.

Drug: Placebo of syntocinon

Interventions

Syntocinon-Spray DRUG

Intranasal oxytocin (24 IU)

Hypertensives with oxytocin and social support; Hypertensives with oxytocin without social support; Normotensives with oxytocin and social support; Normotensives with oxytocin without social support

Placebo of syntocinon DRUG

Intranasal administration

Hypertensives without oxytocin or social support; Hypertensives without oxytocin with social support; Normotensives without oxytocin or social support; Normotensives without oxytocin with social support

Social support BEHAVIORAL

Social support from the best friend

Hypertensives with oxytocin and social support; Hypertensives without oxytocin with social support; Normotensives with oxytocin and social support; Normotensives without oxytocin with social support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 80 years
• sufficient knowledge of German language in reading and understanding
• medication-free
• non-smoking
• systolic blood pressure ≥ 140 \< 180 mmHg and/or diastolic blood pressure ≥ 90 \< 110 mmHg for the hypertension group
• systolic blood pressure \< 140 mmHg and diastolic blood pressure \< 90 mmHg for the normotensive control
• written informed consent

You may not qualify if:

• any alcohol, caffeine, and theine consumption 24 hours before the experiment
• regular strenuous exercise
• alcohol and illicit drug abuse
• liver and renal diseases
• chronic obstructive pulmonary disease
• allergies and atopic diathesis
• rheumatic diseases
• HIV
• cancer
• psychiatric and neurological diseases
• current infectious diseases

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

Department of Psychology, University of Bern

Bern, 3012, Switzerland

Location

Related Links

• Clinical Trial of effects of social support and oxytocin on physiological stress reactivity in essential hypertension

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Petra Wirtz, Prof. Dr.

  University of Konstanz

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 10, 2013
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

CH (1)