Trial · NCT06809166
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MRI Modalities | 4 weeks | Four MRI modalities will be collected during two identical 45-minute MRI session: one at baseline and another 4-weeks post placebo or Contrave. The first modality is an 8-minute resting-state functional MRI to assess brain activity at rest. Second is a 7-minute structural scan, which will allow us to explore potential changes in brain volume. Third, is a 12-minute task-based functional MRI scan where participants are presented with images of food/non-food visual cues, allowing us to assess brain activity in response to different cues. Last is a 9-minute neuromelanin scan, which allows us to visualize neuromelanin in the brain. Neuromelanin is present in brain regions implicated in the brain's reward system and is a marker of dopamine, which is highly involved in motivation and reward. This exploratory scan will help elude neuromelanin levels and locus coeruleus contrast in individuals with obesity and whether there are correlations with other neuroimaging/clinical measures. |
| Primary | Changes in body weight/composition | 4 weeks | Dual Energy X-ray Absorptiometry (DEXA) will be used to measure lean mass, fat mass and percent body fat (Lunar Prodigy, GE Medical Systems) |
| Primary | Brain Activity EEG at Rest | 4 weeks (pre and post contrave or placebo) | Electroencephalography (EEG) at baseline and 4-weeks post placebo or Contrave. EEG will involve a 16-channel EEG system. Data collection includes resting EEG spectral power extracted from resting EEG and may include the following frequency bands: * Delta (1-4 Hz) * Theta (4-8 Hz) * Alpha (8-13 Hz) * Beta (13-30 Hz) * Gamma (\>30 Hz) Analysis: Power is typically analyzed for each frequency band. |
| Primary | Brain Activity During Food Impulsivity Task | 4-weeks (pre and post contrave or placebo) | EEG-derived event-related potentials (ERPs) will be assessed during a food impulsivity task (Go/No-Go task). Specifically, N2 and P3 ERP amplitudes (µV) and latencies (ms) will be measured in response to neutral objects trial, high calorie foods and low calorie foods trials. Behavioural measures, including correct and incorrect responses (%) and reaction times (%) will be measured as secondary outcome measures. |
| Primary | Brain Activity During EEFRT Task | 4-week (pre and post contrave or placebo) | Using the Effort Expenditure for Rewards Task (EEfRT) specific ERPs associated with reward and error processing will be obtained. Specifically, ERP amplitudes (µV) and latencies (ms) for the Stimulus Preceding Negativity (SPN), and the P3 for the easy and hard trials will be analyzed separately. The number of times participants chose the easy vs. hard trials (difficulty) is analyzed as a measure of motivation. |
| Secondary | Hedonic Mechanisms | 4 weeks | Food palatability and appetite ratings (hunger, fullness, desire to eat, and prospective food consumption) will be measured using a 100-mm Visual analog scale (VAS) at fasting, at 0, 30, 60, 90, 120, 180 min after a standardized breakfast administered in the laboratory. Changes in both state and trait-related food craving will be assessed by the self-reported Food Craving Questionnaire. The relative reinforcing value of snack foods in relation to healthy food alternatives will also be assessed. Lunch will be served at approximately 12h30. Participants will be asked to self-select foods from a food menu. They will be instructed to eat as much as they desire of these foods. Energy intake and food preferences will then be assessed from the weight of the different foods consumed. |
| Secondary | Mood | 4 weeks | Self-reports of depression and anxiety symptoms will be assessed using the Beck Depression Inventory (BDI) and the Generalized Anxiety Disorder (GAD-7). These will be collected on an iPad or pen-and-paper (as per participant's preference). Data collected on an iPad will be collected using REDCap (a data collection platform used/available at The Royal, which is known to comply with privacy standards; all imputed data will be only liked with the participant code). The active drug condition (contrave) may influence mood; thus, we will track mood changes before vs. after 4-weeks of intervention. Mood scores (i.e., anxiety and depression) will be used as covariates in the analyses of behavioural and brain activity (MRI, EEG, ERP) measures listed in the primary and secondary outcomes. |
| Secondary | Metabolic Effects | 4 weeks | Resting and Post-Prandial Energy Expenditure: Energy expenditure (EE) will be measured fasting and after a standardized breakfast with indirect calorimetry (Vmax Encore 29N metabolic cart by SensorMedics, Yorba Linda, CA, USA). (approximately 45 min for resting and then 30 min every hour for 2 hours after a standardized breakfast, which will be provided in the laboratory). |
| Secondary | Executive Functioning | 4 weeks | Measured with NIH cognition toolbox. |
| Secondary | Behavioural and EEG During a Delay Discounting Task | 4 weeks (pre and post contrave or placebo) | During a monetary delay discounting task, behavioural data will be collected and will include the number of times participants chose immediate vs delayed reward. Discount rate will also be examined. Spectral power derived from EEG data may be analyzed as a secondary measure. |
| Secondary | Motivation Measures | 4 week | Contrave may influence motivation; thus, we will track motivation changes before vs. after 4-weeks of intervention with the placebo and CONTRAVE®. Using the Behavioural Inhibition System (BIS) and Behavioural Activation System (BAS) will assess motivation and personality-related behaviours. These measures of motivation will be assessed in correlation with measures of: * eating, hunger and food craving collected with the Food Craving Questionnaire. * EEG and ERP measures collected during the food impulsivity task, the effort expenditure task, and the delay discounting task. |
| Secondary | Autonomic Nervous System Measures | 4 weeks | Using a BIOPAC and 5 electrodes, measures of heart rate variability and skin conductance will be collected during the EEG resting state, the food impulsivity task, the effort expenditure task, and the delay discounting task. Heart rate variability and skin conductance measures will be correlated with amplitude (µv), latency (ms), and behavioural (correct responses, incorrect responses, reaction times, number of hard vs easy trials, and immediate vs delayed reward measures extracted from the previously described tasks. |
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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