Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life (LONG-LIFE)
An Examination of Psilocybin Effects on Biomarkers of Longevity, Healthy Aging, and Purpose in Life
The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults.
Up to 50 participants will be enrolled aged 60-80 who will be randomized with equal allocation to one of four intervention groups: (1) receipt of one 25 mg dose of psilocybin; (2) receipt of two 25 mg doses of psilocybin separated by four weeks; (3) receipt of three 25 mg doses, with each dose separated by four weeks; or (4) wait-list comparator condition that does not receive psilocybin. Biomarkers of aging, cognitive performance, and behavioral measures will be assessed at baseline and longitudinally over a 12-month follow-up period. The primary endpoint occurs at the Week 16 visit. Participants randomized to the wait-list condition will be offered a single 25 mg dose of psilocybin following conclusion of the 12-month follow-up period.
Findings from this Phase I study will inform dose selection for a Phase II study should results indicate a potential impact of psilocybin on relevant study endpoints.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Aging is accompanied by progressive changes across multiple physiological systems that contribute to functional decline and increased risk for age-related disease. Biomarkers of biological aging, including DNA methylation-based epigenetic clocks, have emerged as tools for assessing age-related biological processes and predicting future health outcomes.
Recent preclinical studies have suggested that psilocybin and its active metabolite, psilocin, may influence several pathways implicated in aging, including cellular senescence, oxidative stress, neuroplasticity, and epigenetic regulation. In addition to biological effects, observational studies have demonstrated associations between psychosocial factors, including purpose in life and social connectedness, and reduced morbidity and mortality in older adults. Previous clinical studies have shown that psilocybin may produce changes in psychological well-being, meaning, and related constructs.
The LONG-LIFE Study is designed to evaluate multiple domains relevant to healthy aging, including, but not limited to, epigenetic and biological clock measures, cognitive performance, psychosocial well-being, and ecological momentary assessments of daily experience.
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: BHIC Study Team
- Numéro de téléphone: 970-855-7374
- E-mail: bhic@vailhealth.org
Lieux d'étude
-
-
Colorado
-
Edwards, Colorado, États-Unis, 81632
- Vail Health Behavioral Health
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- English speaking and able to provide informed consent and complete study procedures
- Medically healthy, as determined by the screening physician, with no significant medical conditions that would interfere with participation or affect the safety of the subject.
Exclusion Criteria:
- History or presence of any psychiatric or medical condition that, in the opinion of the investigator, could pose a safety risk, interfere with participation, or confound study results.
- Abnormal ECG at screening that may increase risk during participation (e.g., prolonged QTc, arrhythmias, or other clinically significant findings as determined by the study physician).
- Unwilling or unable to discontinue medications that may interfere with study participation, as determined by the investigator.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: One 25mg Dose of Psilocybin
Participants in this arm will receive one 25mg dose of psilocybin paired with therapeutic support.
|
25mg capsule of psilocybin
|
|
Expérimental: Two 25mg Doses of Psilocybin
Participants in this arm will receive two 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
|
25mg capsule of psilocybin
|
|
Expérimental: Three 25mg Doses of Psilocybin
Participants in this arm will receive three 25mg doses of psilocybin approximately 4 weeks apart paired with therapeutic support.
|
25mg capsule of psilocybin
|
|
Aucune intervention: Wait-list Comparator
Participants in this arm will not receive psilocybin as part of the main study but will be given the opportunity to receive a single 25mg dose of psilocybin with therapeutic support after their study participation is complete.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Epigenetic/biological clock profiles; change from Baseline to Week 4 and 16
|
Change from Baseline to Week 4 and Week 16
|
|
Change in Purpose in Life (PIL) from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Change from baseline in Purpose in Life score measured using the 7-item Purpose in Life Scale (PIL) from the Health and Retirement Study (score range 1-6; higher scores indicate greater purpose in life).
|
Change from Baseline to Week 4 and Week 16
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Epigenetic/Biological Clock Profiling from Baseline to Week 52
Délai: Change from Baseline to Week 52
|
Change in Epigenetic/biological clock profile from Baseline to Week 52
|
Change from Baseline to Week 52
|
|
Change in Telomere Length from Baseline to Week 52
Délai: Change from Baseline to Week 52
|
Change from Baseline to Week 52
|
|
|
Change in Purpose in Life (PIL) from Baseline to Week 52
Délai: Change from Baseline to Week 52
|
Change from baseline in Purpose in Life score measured using the 7-item Purpose in Life Scale (PIL) from the Health and Retirement Study (score range 1-6; higher scores indicate greater purpose in life).
|
Change from Baseline to Week 52
|
|
Change in Satisfaction with Life from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Measured using the Satisfaction With Life Scale (SWLS).
Scores range from 5 to 35, where higher scores indicate greater satisfaction with life.
|
Change from Baseline to Week 4 and Week 16
|
|
Change in Wellbeing from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Measured using the Warwick Edinburgh Mental Well-Being Scale (WEMWBS).
Scores range from 14 to 70, with higher scores indicating higher mental wellbeing.
|
Change from Baseline to Week 4 and Week 16
|
|
Change in Optimism from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Measured using the Life Orientation Test - Revised (LOT-R).
Scores range from 0 to 24, with higher scores indicating higher dispositional optimism.
|
Change from Baseline to Week 4 and Week 16
|
|
Change in Perceived Control/Mastery from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Measured using the Pearlin Mastery Scale (PM).
Scores range from 7 to 28; higher totals indicate greater self-mastery.
|
Change from Baseline to Week 4 and Week 16
|
|
Change in Loneliness from Baseline to Week 4 and Week 16
Délai: Change from Baseline to Week 4 and Week 16
|
Measured using the 3-Item UCLA Loneliness Scale (UCLA-3).
Scores range from 3 to 9. Higher scores indicate a greater degree of loneliness.
|
Change from Baseline to Week 4 and Week 16
|
Collaborateurs et enquêteurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20262840
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .