Recruiting

Phase 1

Phase 2

PsilocybinPsilocybin for Amblyopia - Targeting Critical Periods in Humans

Sponsor:

Johns Hopkins University

Code:

NCT07920081

Conditions

Amblyopia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Amblyopia Therapy

1 mg Psilocybin

5 mg Psilocybin

10 mg Psilocybin

15 mg Psilocybin

Study Details

Brief summary:

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.

Conditions

Amblyopia

Study ID

NCT07920081

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1 mg Psilocybin with Amblyopia Therapy

experimental: 5 mg Psilocybin with Amblyopia Therapy

experimental: 10 mg Psilocybin with Amblyopia Therapy

experimental: 15 mg Psilocybin with Amblyopia Therapy

experimental: 20 mg Psilocybin with Amblyopia Therapy

experimental: 25 mg Psilocybin with Amblyopia Therapy

Interventions

Amblyopia Therapy

May include: eye-patching, Bangerter filtering, dichoptic training, perceptual learning

1 mg Psilocybin

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.

5 mg Psilocybin

10 mg Psilocybin

15 mg Psilocybin

20 mg Psilocybin

25 mg Psilocybin

Primary outcome measure

Change in Amblyopic Eye Visual Acuity [ Time Frame: from Baseline to two weeks after experimental drug session 2 ]
Change in Fellow Eye Visual Acuity [ Time Frame: from Baseline to two weeks after experimental drug session 2 ]

Central Contacts and Locations

Central contacts

Brian Winston

410-550-2253 bwinsto2@jh.edu

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Brian Winston

410-550-2253 bwinsto2@jh.edu

Principal Investigator:

Frederick S. Barrett, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 5, 2026

Last verified

Oct, 2026

Keywords

lazy eye
psilocybin
amblyopia
anisometropia
refractive amblyopia
anisometropic amblyopia
psychedelic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.