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| ID | Type | Description | Link |
|---|---|---|---|
| A538900 | Other Identifier | UW- Madison | |
| SMPH/PSYCHIATRY/PSYCHIATRY | Other Identifier | UW- Madison | |
| Protocol Version 12/12/2025 | Other Identifier | UW- Madison |
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| Name | Class |
|---|---|
| Vail Health Foundation | UNKNOWN |
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The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.
Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.
Participants will:
The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Psilocybin and intravenous (IV) midazolam | Experimental | Psilocybin (25 mg) + IV midazolam |
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| Group 2: Psilocybin and IV saline | Experimental | Psilocybin (25 mg) + IV saline (placebo for midazolam) |
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| Group 3: Psilocybin and IV midazolam | Experimental | Psilocybin (1 mg/control) + IV midazolam |
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| Group 4: Psilocybin and IV saline | Experimental | Psilocybin (1 mg/control) + IV saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | 25mg of psilocybin |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS) | WEMWBS is a 14-item questionnaire in which participants describe their experience of each item. It is scored on a 5-point Likert scale, possible range of 14-70 where higher scores indicate higher levels of wellbeing. | Baseline to 7 days post-dose |
| Change in Brief Experiential Avoidance Questionnaire (BEAQ) | The BEAQ is a 15-item questionnaire assessing participants agreement with wellbeing statements. It is scored on a 6-point Likert scale, ranging from 15-90 with higher scores indicating a greater tendency towards experiential avoidance | Baseline to 7 days post-dose |
| Change in Probabilistic Reversal Learning (PRL) | Participants are presented with two stimuli or options and learn which one is more likely to be associated with a reward based on feedback after each trial. After a certain number of trials, the reward contingencies are reversed, meaning the previously advantageous option becomes less likely to be rewarded, and vice versa. The task assesses how quickly and effectively individuals can adapt to these changes in reward contingencies. Researchers analyze various performance metrics, such as the speed of reversal, the number of errors, and the patterns of choices (e.g., win-stay, lose-shift). | Baseline to 7 days post-dose |
| Change in transcranial magnetic stimulation evoked potential (TEP) amplitude | TEP measures neural excitability in the stimulated region of the brain. | Baseline to 7 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in WEMWBS | WEMWBS is a 14-item questionnaire in which participants describe their experience of each item. It is scored on a 5-point Likert scale, possible range of 14-70 where higher scores indicate higher levels of wellbeing. | Baseline to 28 days post-dose |
| Change in BEAQ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RECAP Study Contact | Contact | 608-263-4852 | recap2@psychiatry.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charles Raison, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| Take the pre-screening survey | View source |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| D008874 | Midazolam |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Psilocybin | Drug | 1mg of psilocybin |
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| Midazolam | Drug | The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session. |
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| Saline | Drug | Saline will be administered as a placebo for midazolam |
|
The BEAQ is a 15-item questionnaire assessing participants agreement with wellbeing statements. It is scored on a 6-point Likert scale, ranging from 15-90 with higher scores indicating a greater tendency towards experiential avoidance |
| Baseline to 28 days post-dose |
| Change in PRL | Participants are presented with two stimuli or options and learn which one is more likely to be associated with a reward based on feedback after each trial. After a certain number of trials, the reward contingencies are reversed, meaning the previously advantageous option becomes less likely to be rewarded, and vice versa. The task assesses how quickly and effectively individuals can adapt to these changes in reward contingencies. Researchers analyze various performance metrics, such as the speed of reversal, the number of errors, and the patterns of choices (e.g., win-stay, lose-shift). | Baseline to 28 days post-dose |
| Change in TEP amplitude | TEP measures neural excitability in the stimulated region of the brain. | Baseline to 28 days post-dose |
| Altered States of Consciousness (ASC) questionnaire | Participants will complete a selection of several questions from the ASC questionnaire that strongly associate positively or negatively with later antidepressant effect of psilocybin in patients with treatment resistant depression or capture classic features of the psychedelic experience. During the dosing session, investigator will repeatedly ask selected items from the ASC scale to get a "real time" measure of what the participants are experiencing. Each of these items will be scored separately. Higher score are indicative of a more intense psychedelic experience. | Dosing 1 day |
| Emotional Breakthrough Inventory (EBI) | The EBI is a 6-item scale that assesses the presence and severity of emotionally challenging/distressing experiences that occur during a psychedelic experience. Participants rate to what extent the statements apply to their experience by marking a single line across each scale. Scale ranges from not at all to very much so. Higher scores (more slashes toward the 'very much so' end) on the scale have been associated with enhanced well-being following psychedelic use | Dosing 1 day |
| Psychological Insight Questionnaire (PIQ) | The PIQ is a 23-item instrument designed to query self-perceived attainment of insight during a psychedelic medicine session. Items are rated on a 6-point Likert scale, 0 = no not at all and 5 = extremely. Possible scares range from 0-115, with higher scores indicating greater insight. | Dosing 1 day |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |