Trial · NCT05093296
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Alcohol Urge Questionnaire (AUQ) | 60 minutes after oxytocin/placebo application and directly after the combined stress- and cue-exposure will serve as primary outcome measure at Visit 3 | Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ |
| Secondary | Alcohol Urge Questionnaire (AUQ) | 35 minutes after oxytocin/placebo application at Visit 3 | Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ |
| Secondary | Alcohol Urge Questionnaire (AUQ) | 70 minutes after oxytocin/placebo application at Visit 3 | Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ |
| Secondary | Alcohol Urge Questionnaire (AUQ) | 80 minutes after oxytocin/placebo application at Visit 3 | Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ |
| Secondary | Alcohol Urge Questionnaire (AUQ) | 90 minutes after oxytocin/placebo application at Visit 3 | Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ |
| Secondary | Alcohol Urge Questionnaire (AUQ) | 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4 | Subjective Alcohol Craving will be assessed at separate time points before and after Oxytocin Administration using the AUQ |
| Secondary | Primary Appraisal secondary Appraisal Scale (PASA) | 35 minutes after oxytocin/placebo application at Visit 3 | Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4 |
| Secondary | Primary Appraisal secondary Appraisal Scale (PASA) | 60 minutes after oxytocin/placebo application at Visit 3 | Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4 |
| Secondary | Primary Appraisal secondary Appraisal Scale (PASA) | 90 minutes after oxytocin/placebo application at Visit 3 | Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4 |
| Secondary | Primary Appraisal secondary Appraisal Scale (PASA) | 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4 | Perceived stress will be assessed using the Primary Appraisal secondary Appraisal Scale (PASA) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4 |
| Secondary | Positive and Negative Affect Schedule (PANAS) | 60 minutes after oxytocin/placebo application at Visit 3 | Positive and Negative Affect will be assessed using the Positive and Negative Affect Schedule (PANAS) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4 |
| Secondary | Positive and Negative Affect Schedule (PANAS) | 85 minutes after oxytocin/placebo application, i.e. directly fMRI session at Visit 4 | Positive and Negative Affect will be assessed using the Positive and Negative Affect Schedule (PANAS) at separate time points before and after Oxytocin Administration using the AUQ at Visit 3 and Visit 4 |
| Secondary | Cortisol | 65 minutes after oxytocin/placebo application at Visit 3 | Cortisol plasma levels will be determined using validated Enzyme-linked Immunosorbent Assay (ELISA) methods by the central laboratory at visit 3 after Oxytocin/Placebo administration |
| Secondary | Oxytocin | 30 minutes after oxytocin/placebo application at Visit 3 | Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration |
| Secondary | Oxytocin | 65 minutes after oxytocin/placebo application at Visit 3 | Oxytocin plasma levels will be determined using validated ELISA methods by the central laboratory at visit 3 after Oxytocin/Placebo administration |
| Secondary | Alcohol Cue-induced neural brain activation during an Alcohol cue-reactivity functional magnetic resonance imaging (fMRI) task | During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration | Neural brain activation in the mesocorticolimbic system (whole-brain and Region-of-Interest Analyses (ROIs): ventral striatum, dorsal striatum, insula), measured using the blood oxygenated level dependent (BOLD) response, during presentation of alcohol cues will serve as secondary outcome |
| Secondary | Neural Activation during a natural reward cue-reactivity fMRI task | During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration | Neural brain activation in the mesocorticolimbic system (whole-brain and ROIs: ventral striatum, dorsal striatum, insula), measured using the blood oxygenated level dependent (BOLD) response during the presentation of natural reward cues will serve as secondary outcome |
| Secondary | Neural Activation during a Face-matching fMRI task | During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration | Neural brain activation in the mesocorticolimbic system (whole-brain and ROIs: ventral striatum, dorsal striatum, insula, amygdala), measured using the blood oxygenated level dependent (BOLD) response during the presentation of emotional faces and neutral shapes will serve as secondary outcome |
| Secondary | Neural Activation during a Stop Signal fMRI Task | During fMRI session at Visit 4, i.e. 40 to 85 minutes after Oxytocin/Placebo administration | Neural brain activation in the mesocorticolimbic system (whole-brain and ROIs: ventral striatum, dorsal striatum, insula, dlPFC), measured using the blood oxygenated level dependent (BOLD) response during a stop signal fMRI task will serve as secondary outcome |
| Secondary | Adverse Events (AEs)/Serious Adverse Events (SAEs) and Discontinuation rate | During Study Visits 1 to 6, including the 90 day (±7 day) follow-up period | Rate of adverse events, serious adverse events and rate of discontinuation of the study due to an adverse event |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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