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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Linkopings Universitet

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Behavior and Behavior Mechanisms [F01], Psychiatry and Psychology [F] - Mental Disorders [F03], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

26 Aug 2019 → 13 Aug 2025

Decision date (initial)

2024-10-21

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517598-26-00

EudraCT number

2018-004829-82

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

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.

Secondary objectives 2

1. assess measures of risk aversion using an established Prospect Theory gambling task
2. assess risk taking using the BART (Balloon Analogue Risk Task)

Conditions and MedDRA coding

Gambling disorder

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age 18-65 years.
2. 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.
3. Creatinine ≤ 176 µmol/L.
4. 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.
5. Participant must be willing to receive two IV lines.
6. Inclusion criteria specific for study 1 Participant must be willing to undergo an MR scan.
7. nclusion criteria specific for study 2 Proficiency in Swedish.

Exclusion criteria 9

1. Any clinically significant medical condition, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders.
2. 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.
3. Any use of CNS-active medications.
4. Unable to provide a negative urine drug screen (including amphetamine, THC, opiates and benzodiazepines).
5. Pregnancy, intention to become pregnant, or breastfeeding a child.
6. 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.
7. Exclusion criteria specific for study 1 Contraindications for MRI scanning, including ferromagnetic objects in the body that are contraindicated for MRI, and claustrophobia.
8. 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.
9. Exclusion criteria specific for study 2 Any lifetime history of problematic gambling.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 2

1. 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.
2. The dependent variable will be the mean number of pumps per trial, excluding trials where the balloon explodes in the Balloon Analog Risk Task..

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Linkopings Universitet

Sponsor organisation

Linkopings Universitet

Address

Sandbacksgatan 7, Linkopings Domkyrkofors. Linkopings Domkyrkofors.

City

Linkoping

Postcode

582 25

Country

Sweden

Scientific contact point

Organisation

Linkopings Universitet

Contact name

Markus Heilig

Public contact point

Organisation

Linkopings Universitet

Contact name

Markus Heilig

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 3 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications