E66.9
Conditions
Interventions
Group 1: Patients with obesity or overweight aged 18 to 60 years who are prescribed semaglutide (Wegovy® or Ozempic®) as part of their routine clinical treatment. The study comprises three identical e
Sponsors
Zentralinstitut für Seelische Gesundheit, Klinik für Abhängiges Verhalten und Suchtmedizin, repräsentiert durch
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Men and women between the ages of 18 and 60 who are receiving treatment with Wegovy® or Ozempic® (active ingredient: semaglutide) due to obesity/overweight - Sufficient ability to communicate with the investigators and to answer questions in oral and written form - Ability to give consent after receiving and understanding all the research-related information ("Fully Informed Consent")
Exclusion criteria
Exclusion criteria: - Persons suffering from a mental illness (exceptions: Anxiety disorders, mild to moderate depression, nicotine consumption, alcohol use disorder) - Contraindications for functional magnetic resonance imaging (e.g. metal implants and/or pacemakers that are not suitable for MRI) - Use of psychotropics, painkillers containing opiates or drugs within the last ten days - Withdrawal symptoms at the time of the examination (CIWA score > 3) - Breath alcohol concentration > 0.0 per mille at the time of the examination - Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates, cannabis, benzodiazepines) - Women who are pregnant or breastfeeding - Current severe somatic comorbidities: Liver cirrhosis or severely impaired renal function, severe heart failure, pre-existing epilepsy - Acute suicidal tendencies or acute danger to self or others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the neural brain activation in the Nucleus accumbens, measured using the blood oxygenated level dependent (BOLD) response, during the presentation of visual food and alcohol cues at different stages of the initiation and maintenance of Wegovy® or Ozempic® treatment (i.e. before treatment initiation, 4 weeks into treatment and 16 weeks into treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| I) Neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during alcohol cue presentation in the framework of an alcohol cue-reactivity task at visits 2, 3 and 4. II) Neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during tobacco cue presentation in the framework of a tobacco cue-reactivity task at visit 2, 3 and 4. III) Neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during inhibition of motor responses in the framework of a stop-signal task at visits 2, 3 and 4. IV) Neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during the presentation of emotional faces and neutral shapes in the framework of an emotion-processing task at visit 2, 3 and 4. V) Food cue-induced craving, measured using a visual analogue scale during a food cue-reactivity task at visits 2, 3 and 4. VI) Alcohol cue-induced craving, measured using a visual analogue scale during an alcohol cue-reactivity task at visits 2, 3 and 4. VII) Tobacco cue-induced craving, measured using a visual analogue scale during an tobacco cue-reactivity task at visits 2, 3 and 4. | — |
Countries
Germany
Contacts
Public ContactPatrick Bach
Zentralinstitut für Seelische Gesundheit Mannheim, Klinik für Abhängiges Verhalten und Suchtmedizin
Outcome results
None listed