注意欠陥/多動性障害に対するカンナビゲロールの効果 (CBG)
CBGと注意:注意欠陥/多動性障害の症状および関連する転帰に対するカンナビゲロールの効果を調べる二重盲検、ランダム化、プラセボ対照、クロスオーバー試験
The goal of this clinical trial is to evaluate the effects of Cannabigerol (CBG) on indicators of Attention-Deficit/Hyperactivity Disorder (ADHD) in a sample of participants indicating/reporting symptoms associated with ADHD. The main question it aims to answer is: Does CBG reduce ADHD-related indicators relative to placebo? Participants will administer an acute dose of placebo or 80mg CBG and complete outcome measures at 45 minutes (PANAS only) and 75 minutes. Daily surveys to monitor safety will be administered for one week following administration.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Arkansas
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Fayetteville、Arkansas、アメリカ、72703
- University of Arkansas
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-
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
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Between 18 and 55-years-old.
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BMI between 18 and 35 kg/m2.
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Score a 2 or above on the Adult ADHD Self-Report Scale (ASRS) Symptom Checklist Part A or have an official ADHD diagnosis.
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Meet diagnostic criteria for ADHD with a current severity rating of at least mild as defined by the DIAMOND.
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Are not pregnant or currently breastfeeding.
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Have no history of significant allergic condition, hypersensitivity, or allergic reactions to cannabis, cannabinoid medications, hemp products, medium chain triglyceride oil, or peppermint.
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Have not used CBG or any other cannabinoid products in the past 30 days.
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Willing to abstain from using cannabis or any THC-containing product for the duration of the study.
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Have never used a synthetic cannabinoid or cannabinoid analogue (e.g., dronabinol, nabilone), or a synthetic cannabinoid receptor agonist (e.g., spice, k2).
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Have not been exposed to any investigational drug or device 30 days prior to screening and you have no plans to take an investigational drug during the study.
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Willing to maintain a stable treatment regimen (i.e., no change in current medication use) for the duration of the study.
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Not currently taking a prescription medication for ADHD and have not been prescribed a medication for ADHD in the past six months.
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Not currently having thoughts of committing suicide
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Does not meet criteria for current severe major depressive disorder or a substance use disorder.
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Have not been diagnosed with bipolar disorder or psychosis.
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Do not have an acute illness, such as a respiratory infection or other illness that would interfere with study participation; not currently taking medication for an acute illness (e.g., antibiotic).
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Do not have history of diagnosis related to liver function and/or significantly impaired liver function (e.g., cirrhosis of the liver, hepatitis).
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Willing to ensure they have used effective contraception (for example, oral contraception, double barrier, intra-uterine device) for 30 prior to the study and for 30 days after study completion.
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Have access to a ride to the University of Arkansas campus for research appointments.
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Willing to comply with current university mandates as they pertain to COVID-19 protocols (e.g., mask wearing).
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Do not have any serious or unstable physical health conditions including neurological or renal illness.
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Do not have any current or historical cardiovascular conditions, including hypotension, bradycardia, or heart block.
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No atrial fibrillation, bradycardia, or tachycardia detected via mobile electrocardiogram during the in-laboratory visit.
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No recent illicit drug use other than cannabis, or alcohol use in the 12 hours preceding the in-laboratory visit.
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Not currently prescribed or taking the following medications:
- Warfarin
- Clobazam
- Valproic acid
- Phenobarbital
- Mechanistic Target of Rapamycin [mTOR] Inhibitors
- Oral tacrolimus
- St. John's wort
- Epidiolex
- Escitalopram
- Cardiovascular medications
- Strong CYP3A4 inhibitors (e.g., ketoconazole)
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Cannabigerol
1mL of 80mg of Cannabigerol. Cannabigerol is a safe, legal, non-high-inducing cannabinoid obtained from the cannabis plant. |
1 mL of 80mg Cannabigerol once during experimental session |
|
プラセボコンパレーター:Placebo
1mL of Placebo. Placebo is made in the form of MCT oil. |
1 mL of placebo once during experimental session |
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 |
|---|---|---|
|
Sustained Attention to Response Task
時間枠:75 minutes post CBG/placebo administration
|
A computerized task that measures response inhibition. |
75 minutes post CBG/placebo administration
|
|
Digit Symbol Substitution Test (DSST)
時間枠:75 minutes post CBG/placebo administration
|
A paper-and-pencil task that measures attention/processing speed. |
75 minutes post CBG/placebo administration
|
|
Rey Auditory Verbal Learning Test (AVLT)
時間枠:75 minutes post CBG/placebo administration
|
A paper-and-pencil/verbal test that measures verbal memory. |
75 minutes post CBG/placebo administration
|
|
Iowa Gambling Task (IGT)
時間枠:75 minutes post CBG/placebo administration
|
A computerized task that measures decision making (an indicator of impulsivity/hyperactivity). |
75 minutes post CBG/placebo administration
|
|
Trail Making Test-Parts A and B (TMT-A&B)
時間枠:75 minutes post CBG/placebo administration
|
A paper-and-pencil task that measures attention, psychomotor speed, and cognitive flexibility. |
75 minutes post CBG/placebo administration
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Positive and Negative Affect Scale-Expanded Version
時間枠:Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
|
Self-report measure of positive and negative affect. Scores range from 30-150 on each of the two types of affects, with higher scores representing greater affect. |
Baseline, 45 minutes post CBG/placebo administration, 75 minutes post CBG/placebo administration
|
|
Karolinska Sleepiness Scale
時間枠:Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
Self-report measure of subjective level of sleepiness at a particular time during the day. Scores range from 1-10, with higher scores representing greater sleepiness. |
Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
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Brief Irritability Test
時間枠:Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
Self-report measure of irritability. Scores range from 5-30, with higher scores representing greater irritability. |
Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
|
Numeric Rating Scale (pain)
時間枠:Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
Self-report measure of subjective level of pain. Scores range from 0-10, with higher scores representing greater pain. |
Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
|
State-Trait Anxiety Inventory (State Version)
時間枠:Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
Self-report measure of state anxiety. Scores range from 20 to 80 with higher scores indicating greater anxiety. |
Pre CBG/placebo administration, 75 minutes post CBG/placebo administration
|
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Visual Analog Scales
時間枠:75 minutes post CBG/placebo administration
|
Self-report of state-like states (e.g., anxiety, hunger). This scale ranges from 0 to 100 with higher scores indicating higher levels of the indication. |
75 minutes post CBG/placebo administration
|
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Global Impression of Change
時間枠:75 minutes post CBG/placebo administration
|
Self-report measure of perceived change in ADHD symptoms. This scale ranges from 1 to 7 with higher scores indicating greater improvements. |
75 minutes post CBG/placebo administration
|
協力者と研究者
捜査官
- 主任研究者:Ellen W Leen-Feldner, PhD、University of Arkansas
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- 2309494774
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?
IPD プランの説明
De-identified, individual participant data (including data dictionaries) that underlie results reported in each published report will be shared (text, tables, figures, appendices)
IPD 共有時間枠
Beginning 9months and ending 36 months following publication
IPD 共有アクセス基準
Researchers who provide a methodologically sound proposal. Inquiries should be directed to eleenfe@uark.edu; Requestors will need to sign a data agreement to gain access
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
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
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