Cannabis for Opioid Substitution Trial (COST)
調査の概要
詳細な説明
The search for safer alternatives to opioids for treating chronic cancer and non-cancer pain syndromes currently is an important initiative. Cannabis Research Associates (CRA) has been commissioned by Northern Green Canada Inc. to conduct a multi-phase study that will first define common strains of cannabis that patients use as a replacement for opioids, then conduct a randomized controlled trial to support an application to Health Canada for a Drug Identification Number. This protocol summarizes the methods for phase I.
In total, the Investigators plan to recruit 1,200 adult patients (> 25 years) currently using cannabis to treat chronic cancer and non-cancer pain syndromes conditions. Patients will be recruited from six pain clinics throughout Ontario. Pain clinics have not yet been identified. The study Investigators will invite licensed physicians from various private pain clinics to collaborate on this study.
This is an observational cohort study involving a mixed methods approach. Patients interested in participating will have the option to have an online survey link emailed to them so they can complete the survey at a convenient time. Or, patients can choose to complete the online survey in person with the assistance of a Research Assistant. Research Assistants will have hard copy surveys to serve as a back-up solution should they be faced with Internet connectivity and/or online survey hosting issues. No personal identifying information will be collected. Hard copy data will be stored in locked cabinets and shipped via courier to Cannabis Research Associates in batches.
All aspects of this study will be executed under the supervision of the study Investigators. Scientific independence from the sponsoring body will be maintained, and no censorship of data management, analysis, or presentation/publication will be permitted.
This study will be executed under the approval and ongoing supervision of the Research Ethics Board, as required.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前:Andrea J Afinec, BScH
- 電話番号:647 341-4230
- メール:aafinec@gmail.com
研究場所
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Ontario
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Hamilton、Ontario、カナダ
- 募集
- Synergy Health Services Inc.
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コンタクト:
- Ira Price, MD FRCPC
- 電話番号:1-855-800-2226
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adult patients aged > 25 years-CPSO Policy states that physicians cannot prescribe medical cannabis to persons under the age of 25 unless all other conventional therapies have failed. Furthermore, there is evidence to support that cannabis use in younger persons can have lasting effects since the brain is still developing (Wier K, 2015).
- English-speaking, or with the assistance of a family member/friend that can interpret English for the patient.
- Qualifying medical diagnosis for appropriate use of medical cannabis by a licensed physician.
- Current medical cannabis use to treat chronic cancer and non-cancer pain syndromes.
- Current or past use of prescription opioids to treat chronic cancer and non-cancer pain syndromes.
Exclusion Criteria:
1. Patients taking medical cannabis for reasons other than chronic cancer and non-cancer pain syndromes
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
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 |
---|---|---|
Cannabis as replacement for opioids
時間枠:Through study completion, an average of 1 year
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Define common strains of cannabis that patients are using as a replacement for opioids (should any exist)
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Through study completion, an average of 1 year
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協力者と研究者
捜査官
- 主任研究者:Ira Price, MD、Cannabis Research Associates
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
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。
Medical Cannabisの臨床試験
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Soterix MedicalGeorgetown University; National Institute of Neurological Disorders and Stroke (NINDS); University... と他の協力者完了
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