Effects of the appetite-inducing hormone ghrelin on decision making in healthy volunteers

Phase 2

Recruiting

• Conditions: Gambling disorder

• Registration Number: 2024-517598-26-00
• Lead Sponsor: Linkopings Universitet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 74

Inclusion 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The dependent variable will be the total number of spins the participant carries out in the Slot Machine task.		The dependent variable will be the total number of spins the participant carries out in the Slot Machine task.

Secondary Outcome Measures

Name	Time	Method
The dependent variable will be the proportion of trials in which the participant gambled, i.e.; chose the option with an uncertain over that with a certain outcome in the Gambling Task.		The dependent variable will be the proportion of trials in which the participant gambled, i.e.; chose the option with an uncertain over that with a certain outcome in the Gambling Task.
The dependent variable will be the mean number of pumps per trial, excluding trials where the balloon explodes in the Balloon Analog Risk Task..		The dependent variable will be the mean number of pumps per trial, excluding trials where the balloon explodes in the Balloon Analog Risk Task..

Trial Locations

Locations (1)

Region Oestergoetland; 🇸🇪 Linkoping, Sweden

Region Oestergoetland

🇸🇪Linkoping, Sweden

Markus Heilig

Site contact

+46700850769

markus.heilig@liu.se