RECAP 2 Psilosybiinin käyttäytymisvaikutuksissa
Kokemuksen, tietoisen tietoisuuden ja plastisuuden rooli psilosybiinin käyttäytymisvaikutuksissa – seurantatutkimus (The RECAP 2 -tutkimus)
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:
- Receive one of four possible combinations of medications
- Undergo an MRI
- Complete questionnaires
- Undergo transcranial magnetic stimulation (TMS) and EEG
- Volunteer for an open-label follow-up phase of study
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: RECAP Study Contact
- Puhelinnumero: 608-263-4852
- Sähköposti: recap2@psychiatry.wisc.edu
Opiskelupaikat
-
-
Wisconsin
-
Madison, Wisconsin, Yhdysvallat, 53792
- Rekrytointi
- UW School of Medicine and Public Health
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Age 18 to 65 years at screening, of any identified gender and racial/ethnic group
- Physically healthy; does not meet criteria for an exclusionary medical condition
- English-speaking (able to provide consent and complete questionnaires)
- Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder
- Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)
Exclusion Criteria:
- Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
- Exclusionary medical conditions
- Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
- Clinically significant electrocardiogram (ECG)
- Use of psychotropic or CNS-altering medications within 3 months of screening
- Hypertension or tachycardia
Participants invited to participate in the 28-day open label follow-up phase will:
-
Fully complete all activities associated with the randomized phase, including the virtual Day 84 assessment, before being approached about participation in the open label phase.
-
Participants who meet stopping criteria during the randomized phase are not eligible to enroll in the open label phase.
-
Participants who withdraw from the randomized phase are not eligible to enroll in the open label phase.
-
Enrollment into the open label phase must occur in the following sequence:
- participants who have fully completed the randomized phase are screened for eligibility;
- eligible participants meet with the study team and provide informed consent for the open label phase;
- baseline eligibility is reassessed to confirm that participation in the open label phase remains appropriate and safe.
The Principal Investigator may decline or defer open-label enrollment when unresolved concerns make participation unsafe or scientifically inappropriate.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Group 1: Psilocybin and intravenous (IV) midazolam
Psilocybin (25 mg) + IV midazolam |
25mg of psilocybin
Muut nimet:
1mg of psilocybin
Muut nimet:
The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session. |
|
Kokeellinen: Group 2: Psilocybin and IV saline
Psilocybin (25 mg) + IV saline (placebo for midazolam) |
25mg of psilocybin
Muut nimet:
1mg of psilocybin
Muut nimet:
Saline will be administered as a placebo for midazolam |
|
Kokeellinen: Group 3: Psilocybin and IV midazolam
Psilocybin (1 mg/control) + IV midazolam |
25mg of psilocybin
Muut nimet:
1mg of psilocybin
Muut nimet:
The goal of the midazolam dosing regimen is to induce amnesia of the psychedelic experience without inducing over-sedation during the dosing session. |
|
Kokeellinen: Group 4: Psilocybin and IV saline
Psilocybin (1 mg/control) + IV saline |
25mg of psilocybin
Muut nimet:
1mg of psilocybin
Muut nimet:
Saline will be administered as a placebo for midazolam |
|
Kokeellinen: Exploratory Open Label Follow-Up Phase
Psilocybin (25 mg) |
25mg of psilocybin
Muut nimet:
1mg of psilocybin
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)
Aikaikkuna: Baseline to 7 days post-dose
|
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)
Aikaikkuna: Baseline to 7 days post-dose
|
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)
Aikaikkuna: Baseline to 7 days post-dose
|
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
Aikaikkuna: Baseline to 7 days post-dose
|
TEP measures neural excitability in the stimulated region of the brain. |
Baseline to 7 days post-dose
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in WEMWBS
Aikaikkuna: Baseline to 28 days post-dose
|
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
Aikaikkuna: Baseline to 28 days post-dose
|
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
Aikaikkuna: Baseline to 28 days post-dose
|
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
Aikaikkuna: Baseline to 28 days post-dose
|
TEP measures neural excitability in the stimulated region of the brain. |
Baseline to 28 days post-dose
|
|
Altered States of Consciousness (ASC) questionnaire
Aikaikkuna: Dosing 1 day
|
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)
Aikaikkuna: Dosing 1 day
|
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)
Aikaikkuna: Dosing 1 day
|
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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Charles Raison, MD, University of Wisconsin, Madison
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Alkaloidit
- Indolit
- Epäorgaaniset kemikaalit
- Klooriyhdisteet
- Indolialkaloidit
- Indolitsidiinit
- Indolisoija
- Bentsazepiinit
- Bentsodiatsepiinit
- Tryptaminit
- Natriumyhdisteet
- Kloridit
- Suolahappo
- Midatsolaami
- Psilosybiini
- Natriumkloridi
Muut tutkimustunnusnumerot
- 2024-0852
- A538900 (Muu tunniste: UW- Madison)
- SMPH/PSYCHIATRY/PSYCHIATRY (Muu tunniste: UW- Madison)
- Protocol Version 9/30/2026 (Muu tunniste: UW- Madison)
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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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