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Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers
EU CTIS ID: 2024-517598-26-00
What this study is testing
Study 1: The primary objective of this protocol is to investigate whether IV ghrelin will alter decision making processes including those that involve a) evaluation of reward; b) propensity to take on risk; c) trading off of small immediate rewards vs larger, temporally more distant ditto (delay discounting), and d) goal-directed learning; as well as the neural substrates associated with these decision making processes, measured using fMRI. Study 2: The primary objective of the protocol is to investigate whether IV ghrelin will affect sensitivity to losses in a gambling environment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-65 years.
- Good health as determined by medical history, ECG and clinical assessment of lab tests. Lab tests will include sodium, potassium, creatinine, hemoglobin, EVF, erythrocytes, leukocytes, platelets, MCV, MCH, MCHC, albumin, bilirubin, plasma lipids, ALP, ASAT, ALAT, CRP, GT. The final decision will be according to the judgment of the investigator.
- Creatinine ≤ 176 µmol/L.
- 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.
- Participant must be willing to receive two IV lines.
- Inclusion criteria specific for study 1 Participant must be willing to undergo an MR scan.
You likely can't join if
- Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Specific exclusion criteria related to the administration of ghrelin are chronic inflammatory diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease), diabetes, obesity (BMI ≥ 30 kg/m2), weight ≥ 120 kg, high triglycerides level (> 4,0 mmol/l), history of clinically significant hypotension (e.g., history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.
- Any use of CNS-active medications.
- Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
- Pregnancy, intention to become pregnant, or breastfeeding a child.
- Exclusion criteria specific for study 1 Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine; any history of a past eating disorder, psychotic illness, or bipolar disorder; as determined by medical history, and MINI interview carried out by appropriately trained staff.
See the full eligibility criteria
- Age 18-65 years.
- Good health as determined by medical history, ECG and clinical assessment of lab tests. Lab tests will include sodium, potassium, creatinine, hemoglobin, EVF, erythrocytes, leukocytes, platelets, MCV, MCH, MCHC, albumin, bilirubin, plasma lipids, ALP, ASAT, ALAT, CRP, GT. The final decision will be according to the judgment of the investigator.
- Creatinine ≤ 176 µmol/L.
- 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.
- Participant must be willing to receive two IV lines.
- Inclusion criteria specific for study 1 Participant must be willing to undergo an MR scan.
- nclusion criteria specific for study 2 Proficiency in Swedish.
- Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
- Specific exclusion criteria related to the administration of ghrelin are chronic inflammatory diseases (e.g., Crohn’s disease, ulcerative colitis, celiac disease), diabetes, obesity (BMI ≥ 30 kg/m2), weight ≥ 120 kg, high triglycerides level (> 4,0 mmol/l), history of clinically significant hypotension (e.g., history of fainting and/or syncopal attacks) and/or resting systolic BP < 100 mmHg.
- Any use of CNS-active medications.
- Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
- Pregnancy, intention to become pregnant, or breastfeeding a child.
- Exclusion criteria specific for study 1 Any current clinically significant psychiatric problems including a diagnosis of substance dependence other than nicotine; any history of a past eating disorder, psychotic illness, or bipolar disorder; as determined by medical history, and MINI interview carried out by appropriately trained staff.
- Exclusion criteria specific for study 1 Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
- Exclusion criteria specific for study 2 Any current clinically significant psychiatric problems including a DSM-5 diagnosis of severe Substance Use Disorder other than nicotine, or Gambling Disorder. Patients will be screened using the Modified MINI Screen [MMS], the Alcohol Use Disorder Identification Test [AUDIT], the Drug Use Disorder Identification Test (DUDIT] and the NORC Diagnostic Screen for Gambling Problems [NODS]. The results and their clinical significance will be evaluated by a trained healthcare professional (psychiatrically trained nurse or physician). If an indication is obtained that a clinically significant psychiatric disorder may be present, a full structured diagnostic interview [MINI] will be carried out by appropriately trained staff prior to determining eligibility.
- Exclusion criteria specific for study 2 Any lifetime history of problematic gambling.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.