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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前：Brian Winston
- 電話番号：410-550-2253
- メール：bwinsto2@jh.edu
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21224
- 募集
- Johns Hopkins Center for Psychedelic and Consciousness Research
-
主任研究者：
- Frederick S. Barrett, PhD
-
コンタクト：
- Brian Winston
- 電話番号：410-550-2253
- メール：bwinsto2@jh.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1 mg Psilocybin with Amblyopia Therapy
|
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. |
|
実験的：5 mg Psilocybin with Amblyopia Therapy
|
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. |
|
実験的：10 mg Psilocybin with Amblyopia Therapy
|
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. |
|
実験的：15 mg Psilocybin with Amblyopia Therapy
|
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. |
|
実験的：20 mg Psilocybin with Amblyopia Therapy
|
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. |
|
実験的：25 mg Psilocybin with Amblyopia Therapy
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Amblyopic Eye Visual Acuity
時間枠：from Baseline to two weeks after experimental drug session 2
|
Measured using LogMAR scale |
from Baseline to two weeks after experimental drug session 2
|
|
Change in Fellow Eye Visual Acuity
時間枠：from Baseline to two weeks after experimental drug session 2
|
Measured using LogMAR scale |
from Baseline to two weeks after experimental drug session 2
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Challenging Experiences Questionnaire (CEQ)
時間枠：Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
|
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).
|
|
11-Dimensional Altered States of Consciousness Questionnaire (11D-ASC)
時間枠：Approximately 7 hours after capsule administration during each experimental drug administration session (Visits 3 and 7; two weeks apart).
|
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).
|
|
The World Health Organization-Five Well-Being Index (WHO-5)
時間枠：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.
|
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.
|
|
Amblyopia and Strabismus Questionnaire: English (ASQE)
時間枠：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
|
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
|
|
Sheehan Disability Scale (SDS)
時間枠：At the preparation session, two weeks after the first drug administration session, and two and eight weeks after the second drug administration session.
|
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.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Frederick Barrett, MD、Johns Hopkins University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00519391
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。