Cannabinoids and Cerebellar-Motor Functioning
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
Connecticut
-
West Haven、Connecticut、アメリカ、06516
- VA Connecticut Healthcare System
-
-
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:
- Must have used cannabis at least once in their lifetime
- No cannabis use in the past month
- Men and women aged 21 to 35 years (extremes included) on the day of the first dosing
Exclusion Criteria:
- Hearing deficits
- Psychiatric or mental disorders
- Hearing Deficits
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：他の
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- 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 |
|---|---|
|
アクティブコンパレータ：THC
Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. |
Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes. |
|
プラセボコンパレーター：Placebo
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
|
Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.
|
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 |
|---|---|---|
|
Cerebellum Dependent Associative Learning (% CRs)
時間枠：Measured +15 minutes after infusion
|
% conditioned responses (CRs) will be measured
|
Measured +15 minutes after infusion
|
|
Cerebellum Dependent Associative Learning (CR Latency)
時間枠：Measured +15 minutes after infusion
|
conditioned response (CR) Latency will be measured
|
Measured +15 minutes after infusion
|
|
Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)
時間枠：Measured +45 minutes after infusion
|
Total time taken to complete the grooved pegboard tasks will be the dependent measure.
|
Measured +45 minutes after infusion
|
|
CANTAB Motor Screening Test (Reaction Time)
時間枠：Measured +45 minutes after infusion
|
Using a touch screen, reaction time to touch a target will be the dependent measures.
|
Measured +45 minutes after infusion
|
|
CANTAB Motor Screening Test (Accuracy)
時間枠：Measured +45 minutes after infusion
|
Using a touch screen, accuracy to touch a target will be the dependent measures.
|
Measured +45 minutes after infusion
|
|
Paced Finger Tapping (Correct Responses)
時間枠：Measured +45 minutes after infusion
|
Using a button on a computer keyboard, correct responses will be measured.
|
Measured +45 minutes after infusion
|
|
Paced Finger Tapping (Reaction Time)
時間枠：Measured +45 minutes after infusion
|
Using a button on a computer keyboard, reaction time and tapping variability will be measured.
|
Measured +45 minutes after infusion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
THC intoxication, as measured by the Visual Analog Scale (Total Score)
時間枠：Baseline; +45, +100, +240 minutes after infusion
|
0 being none; 100 being completely
|
Baseline; +45, +100, +240 minutes after infusion
|
協力者と研究者
スポンサー
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 (見積もり)
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
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。
THCの臨床試験
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)完了
-
Johns Hopkins UniversitySubstance Abuse and Mental Health Services Administration (SAMHSA)完了
-
University of California, San DiegoCenter for Medicinal Cannabis Researchまだ募集していません
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)募集