Study on the Effects of Morphine Hydrochloride on Stress and Social Interaction in Healthy Volunteers

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What is this study about?

This clinical trial is focused on understanding how the medication morphine affects stress responses and social interactions in healthy individuals. Morphine is a well-known pain relief medication that belongs to a group of drugs called opioids. The study will also use a solution called 0.9% Sodium Chloride, which is commonly used in medical settings as a fluid replacement. The main goal of the study is to explore how morphine influences the brain, body, and feelings when people experience emotional distress, such as feeling rejected.

Participants in the study will receive either morphine or a placebo through an injection. The study will observe how these substances affect the participants’ reactions to social situations that might cause stress or discomfort. This includes looking at changes in brain activity using a method called fMRI, which is a type of brain scan that shows how the brain is working. The study will also measure how participants feel and how their bodies respond to stress, including checking levels of certain stress-related substances in the body.

The study is designed to last for a short period, with participants attending sessions where they will receive the treatment and undergo various assessments. The findings from this study could help improve understanding of how morphine affects emotional and social responses, which might be useful for developing new treatments for stress-related conditions in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, an electrocardiogram (ECG), and various lab tests. These tests check levels of potassium, creatinine, hemoglobin, glucose, calcium, blood urea nitrogen (BUN), and other important markers.

Females are required to take a urine pregnancy test at the start of each study session. Participants must be right-handed and have prior experience with medical opioids.

2 consent and preparation

Participants provide informed consent, agreeing to the study’s terms and conditions. This includes understanding the study’s objectives and procedures.

Participants must agree to receive two intravenous (IV) lines and undergo a magnetic resonance (MR) scan.

3 medication administration

Participants receive **morphine hydrochloride** through an intravenous injection. The dosage is 10 mg/ml, administered as a solution for injection.

Additionally, a **0.9% sodium chloride** solution is used for intravenous infusion. This helps maintain fluid balance during the study.

4 study sessions

Participants undergo sessions where the effects of morphine on stress response and social interaction are observed. This includes measuring subjective distress using a visual analog scale and neural responses using functional magnetic resonance imaging (fMRI).

The study also examines behavioral and physiological responses to social interactions, such as personal distance and social approach or avoidance.

5 biomarker analysis

The study evaluates stress-related biomarkers, such as cortisol and endocannabinoid levels, to understand their interaction with morphine.

These biomarkers help assess the physiological impact of social rejection and the potential moderating effects of morphine.

6 completion and feedback

Upon completing the study, participants may receive feedback on their individual results and the overall findings of the study.

The study is estimated to conclude by June 15, 2025.

Who Can Join the Study?

Age between 18 and 65 years old, and willing to provide informed consent.
In good health as determined by medical history, heart test (ECG), and lab tests. Lab tests will check things like potassium, creatinine, hemoglobin, glucose, calcium, and others. The final decision will be made by the lead doctor.
Ability to speak and understand Swedish.
Females must have a negative urine pregnancy test at the start and during the study. Females who can become pregnant and are sexually active must agree to use a reliable method of birth control during the study.
Willingness to have two IV lines (a way to give medicine directly into the vein) and undergo an MR scan (a type of imaging test).
Must be right-handed, as determined by a specific test called the Edinburgh Handedness Inventory (EHI).
Must have prior experience with medical opioids, such as having used medicines like oxycodone, morphine, hydrocodone, codeine, or dihydrocodeine at least once before.

Who Cannot Join the Study?

Participants must be healthy volunteers. This means they should not have any significant medical conditions.
Participants should not be part of a vulnerable population. This refers to groups who may have limited ability to give informed consent or may be at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Oestergoetland	Linkoping	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.02.2022

Trial locations

Investigated drugs:

Morphine is a medication that is commonly used to relieve pain. In this study, it is being used to explore how it affects the body’s response to stress and social interactions. Researchers are interested in understanding how morphine influences the brain, body, and feelings when a person experiences emotional distress, such as feeling rejected. By studying these effects in healthy individuals, scientists hope to learn more about how morphine works and its potential impact on emotional and social experiences.

Healthy volunteers – Healthy volunteers are individuals who do not have the disease or condition being studied. They participate in clinical trials to provide baseline data for comparison with affected individuals. In studies, they help researchers understand the normal progression of physiological and psychological responses. Healthy volunteers are crucial for determining the effects of interventions, such as medications, on normal biological processes. Their participation helps in identifying potential side effects and understanding the body’s typical reactions. They serve as a control group to ensure the accuracy and reliability of clinical research findings.

Trial ID:

2024-517855-10-00

Protocol code:

MOR-STRESS-SI

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Morphine Hydrochloride on Stress and Social Interaction in Healthy Volunteers

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