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Study of Ghrelin's Effects on Decision-Making and Gambling Behavior in Healthy Adults: Comparison with Placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines how lenomorelin (also known as ghrelin), an appetite-stimulating hormone, affects decision-making processes in relation to gambling disorder. The research focuses on understanding how this hormone might influence how people make choices, particularly in situations involving rewards and risks.

During the study, participants will receive either Acyl Ghrelin or sodium chloride solution through an intravenous infusion. The hormone will be administered in carefully controlled doses while participants complete various decision-making tasks. Some participants will also undergo brain imaging using fMRI (functional magnetic resonance imaging) to observe how the hormone affects brain activity during these tasks.

The research consists of two separate studies. The first study looks at how the hormone affects different types of decision-making and brain activity. The second study specifically examines how the hormone influences how people respond to losses in gambling situations. Both studies aim to better understand the relationship between this natural hormone and decision-making behaviors.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial preparation
You will receive two intravenous (IV) lines - small tubes inserted into your veins for medication administration
A pregnancy test will be performed if you are a female of childbearing age
Step 2
Medical assessment
Your health status will be evaluated through various laboratory tests, including blood tests that check your liver function, kidney function, and blood cell counts
An ECG (heart rhythm test) will be performed
Step 3
Study medication administration
You will receive two medications through the IV lines:
- 0.9% Sodium Chloride solution (common IV fluid)
- Acyl Ghrelin 0.25 mg (appetite-stimulating hormone)
Step 4
Decision-making tasks
You will participate in several tasks that measure decision-making:
- Slot Machine task: Playing a simulated slot machine game
- Gambling Task: Making choices between certain and uncertain outcomes
- Balloon Task: Making decisions about risk-taking
Step 5
Brain imaging
If participating in study 1, you will undergo an MRI scan (magnetic resonance imaging) to monitor brain activity during the tasks
The scan will take place in a specialized imaging machine
Step 6
Study completion
The IV lines will be removed
Final health assessment will be performed to ensure your well-being

Who can join the trial?

10 criteria

Age between 18 and 65 years
Must be in good health, confirmed by:
- Medical history review
- ECG (heart electrical activity test)
- Laboratory tests including blood counts, liver function, kidney function, and other standard blood tests
- Kidney function test (creatinine) must be equal to or below 176 µmol/L
- For female participants:
  - Must have negative pregnancy tests before each study session
  - If able to become pregnant and sexually active, must use effective birth control during the study
  - Must be willing to have two intravenous (IV) lines placed
  - For Study 1 participants:
    
    Must be willing to undergo an MR scan (magnetic resonance imaging)
    For Study 2 participants:
    
    Must be fluent in Swedish language

Who cannot join the trial?

14 criteria

Age below 18 or above 65 years
Current or history of significant medical conditions that could affect brain function
Current pregnancy or breastfeeding
History of severe psychiatric disorders (other than gambling disorder)
Current use of medications that could interact with the study drug (ghrelin)
Inability to undergo MRI scanning (such as having metal implants, pacemakers, or claustrophobia)
History of substance abuse or dependence in the past 6 months
Abnormal blood test results
Unable to provide informed consent
Participation in another clinical trial within the past 30 days
Known allergies to ghrelin or similar substances
Conditions that could interfere with intravenous (IV) administration of medication
History of severe head injury or neurological conditions
Inability to complete study assessments

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Region Oestergoetland
Responsive
Linkoping, Sweden

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Investigated drugs

Ghrelin is a naturally occurring hormone that stimulates appetite and hunger. In this trial, it is administered intravenously (through a vein) to study how it affects decision-making processes in the brain. This hormone is known to play a role in regulating food intake and energy balance. Researchers are studying how ghrelin influences various aspects of decision-making, including how people evaluate rewards, assess risks, and make choices about immediate versus future rewards.

What is already known about the treatment

Ghrelin - An intravenously administered peptide hormone that naturally stimulates appetite and hunger in the human body. This hormone is being investigated in clinical trials for its effects on decision-making processes and reward evaluation, particularly in relation to gambling behavior and risk assessment. Ghrelin works by binding to specific receptors in the brain, particularly in areas associated with reward processing, motivation, and decision-making, such as the hypothalamus and mesolimbic reward system. As a pharmacological agent, it belongs to the class of peptide hormones and is currently used primarily in research settings to study its influence on human behavior and neural mechanisms related to reward processing and risk-taking decisions.

Investigated diseases

Gambling Disorder - A behavioral addiction characterized by persistent and recurrent problematic gambling behavior that leads to significant impairment or distress. The condition involves increasing preoccupation with gambling, needing to gamble with increasing amounts of money to achieve desired excitement, repeated unsuccessful efforts to control or stop gambling, and continuing to gamble despite negative consequences. People with this disorder often experience restlessness or irritability when attempting to cut down or stop gambling, and may gamble to escape problems or relieve negative moods. The disorder can disrupt personal relationships, work performance, and financial stability.