Psilocybin for Amblyopia - Targeting Critical Periods in Humans (PATCH)
Psilocybin for Amblyopia - Targeting Critical Periods in Humans (PATCH)
The purpose of this study is to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms. It can be ingested orally and can result in strong but short-term (4-6 hours) effects such as changes in perception, thoughts, and emotions.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Participation in this study involves up to 12 visits over 9-13 weeks, including a screening visit, a preparation visit, two all-day experimental drug administration sessions with psilocybin, and eight follow up visits.The purpose of these follow-up visits is to deliver in-lab amblyopia therapy, measure visual function, and monitor safety. Participants will also be asked to complete amblyopia therapy at home: this will involve wearing an eyepatch or an eyeglasses filter over the non-amblyopic eye every day for up to several hours and completing online training exercises.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Brian Winston
- Numéro de téléphone: 410-550-2253
- E-mail: bwinsto2@jh.edu
Lieux d'étude
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Maryland
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Baltimore, Maryland, États-Unis, 21224
- Recrutement
- Johns Hopkins Center for Psychedelic and Consciousness Research
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Chercheur principal:
- Frederick S. Barrett, PhD
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Contact:
- Brian Winston
- Numéro de téléphone: 410-550-2253
- E-mail: bwinsto2@jh.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18 to 65 years old
- Have given written informed consent
- Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English
- Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, medical history and physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
- Women who are of child-bearing potential and sexually active agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study
- Agree to consume approximately the same amount of caffeine-containing beverage (e.g. coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.
- Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
- Agree not to take any as needed (PRN) medications on the mornings of drug sessions
- Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
- Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
- Have a clinical diagnosis of amblyopia, with best-corrected visual acuity in the range of 0.2 - 1.0 LogMAR (approximately equivalent to 20/30 to 20/200)
- Has undergone an eye exam and prescription assessment within a recent period
- Has been wearing current spectacle correction for a minimum of six weeks prior to enrollment
Exclusion Criteria:
- Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of birth control (i.e. those that result in <1% failure rate per year; note that condoms alone are not considered highly effective)
- Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation), artificial heart valve, or transient ischemic attack (TIA) in the past year
- Epilepsy with history of seizures
- Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
- Currently taking on a regular (e.g. daily) basis any medications having a primary centrally-acting serotonergic effect, including monoamine oxidase inhibitor (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.
- Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition)
- Current or past history within the last five years of meeting DSM-5 criteria for a severe alcohol or drug use disorder (excluding caffeine and nicotine)
- Have a first-degree relative with bipolar I disorder, schizophrenia spectrum, or other psychotic disorders (except substance/medication-induced or due to another medical condition)
- Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin
- Explanation for visual acuity loss other than amblyopia, including cataracts, corneal disease, optic neuropathy, retinopathy, glaucoma, history of eye trauma or intraocular surgery, or any other ocular pathology as determined by study ophthalmologist
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 1 mg Psilocybin with Amblyopia Therapy
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May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 1 mg of psilocybin. |
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Expérimental: 5 mg Psilocybin with Amblyopia Therapy
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May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 5 mg of psilocybin. |
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Expérimental: 10 mg Psilocybin with Amblyopia Therapy
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May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 10 mg of psilocybin. |
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Expérimental: 15 mg Psilocybin with Amblyopia Therapy
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May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 15 mg of psilocybin. |
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Expérimental: 20 mg Psilocybin with Amblyopia Therapy
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May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 20 mg of psilocybin. |
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Expérimental: 25 mg Psilocybin with Amblyopia Therapy
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May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 25 mg of psilocybin. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Amblyopic Eye Visual Acuity
Délai: from Baseline to two weeks after experimental drug session 2
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Measured using LogMAR scale |
from Baseline to two weeks after experimental drug session 2
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Change in Fellow Eye Visual Acuity
Délai: from Baseline to two weeks after experimental drug session 2
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Measured using LogMAR scale |
from Baseline to two weeks after experimental drug session 2
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Challenging Experiences Questionnaire (CEQ)
Délai: Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
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The Challenging Experience Questionnaire (CEQ) is a self-report measure designed to assess the intensity and quality of difficult or distressing experiences during psychedelic states. Score range 0-5, 0 is equivalent to no challenging experiences and 5 is an extreme (more than ever before in my life). Higher score "more difficult." |
Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
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11-Dimensional Altered States of Consciousness Questionnaire (11D-ASC)
Délai: Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
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The 11D-ASC is a self-report questionnaire designed to assess the phenomenology of altered states of consciousness induced by psychedelics and other methods. The 11 dimensions are: 1) Experience of Unity, (2) Spiritual Experience, (3) Blissful State, (4) Insightfulness, (5) Disembodiment, (6) Impaired Control and Cognition, (7) Anxiety, (8) Complex Imagery, (9) Elementary Imagery, (10) Audio-Visual Synesthesia, and (11) Changed Meaning of Percepts. Each item is rated on a visual analog scale from 0 to 100, and scores for each dimension are calculated as the mean of the corresponding items, ranging from 0 to 100. Higher scores indicate greater intensity of the respective subjective experience, rather than a uniformly better or worse outcome. |
Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
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The World Health Organization-Five Well-Being Index (WHO-5)
Délai: At the preparation session, one and two weeks after the first experimental drug administration session, and one, two, and eight weeks after the second drug administration session.
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The WHO-5 is a five-item self-report measure of mental well-being over the preceding two weeks. Each item is scored from 0 to 5, yielding a raw total score ranging from 0 to 25. The raw score can be multiplied by four to obtain a percentage score ranging from 0 to 100. Higher scores indicate better mental well-being. |
At the preparation session, one and two weeks after the first experimental drug administration session, and one, two, and eight weeks after the second drug administration session.
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Amblyopia and Strabismus Questionnaire: English (ASQE)
Délai: At the preparation session, two weeks after the first experimental drug administration session, and two and eight weeks after the second experimental drug administration session
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The ASQE is a 26-item self-report questionnaire assessing vision-related quality of life in adults with amblyopia and strabismus. Item responses are converted to scores ranging from 0 to 100, and the total score is calculated as the mean of the item scores, ranging from 0 to 100. Higher scores indicate better vision-related quality of life, with 0 representing the worst and 100 the best possible outcome. |
At the preparation session, two weeks after the first experimental drug administration session, and two and eight weeks after the second experimental drug administration session
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Sheehan Disability Scale (SDS)
Délai: At the preparation session, two weeks after the first drug administration session, and two and eight weeks after the second drug administration session.
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The Sheehan Disability Scale (SDS) is a patient-rated questionnaire assessing functional impairment across three domains: work/school, social life, and family life/home responsibilities. Each domain is rated on an 11-point scale from 0 (no impairment) to 10 (extreme impairment). The three domain scores are summed to yield a total score ranging from 0 to 30. Higher scores indicate greater functional impairment (worse functioning), while lower scores indicate less impairment (better functioning). |
At the preparation session, two weeks after the first drug administration session, and two and eight weeks after the second drug administration session.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Frederick Barrett, MD, Johns Hopkins University
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
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies oculaires
- Erreurs de réfraction
- Troubles de la vision
- Troubles des sensations
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Amblyopie
- Anisométropie
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Alcaloïdes
- Indoles
- Alcaloïdes indole
- Indolizidines
- Indolizines
- Tryptamines
- Psilocybine
Autres numéros d'identification d'étude
- IRB00519391
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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