また別の裁判が失敗した
C C Cook1, T D Scannell, M S Lipsedge
1Department of Psychiatry, United Medical School, Guy's Hospital, London.
Lancet (London, England)
|March 5, 1988
まとめ
クロニジンとロフェキシジンを用いたオピオイド離脱管理に関するこの研究は,非科学的な問題のために終了されました. これらの課題は,中毒治療のための臨床試験を実施する際の実践的な困難を強調しています.
科学分野:
- 薬理学 薬理学とは
- クリニック・リサーチ 臨床研究
- 依存症医学 薬物中毒医学
背景:
- オピオイド離脱症候群 (OWS) の管理は極めて重要です.
- クロニジンとロフェキシジンは,OWSの潜在的な治療法です.
- 臨床試験は,科学的価値を超えた多面的な課題に直面しています.
研究 の 目的:
- OWSの管理におけるクロニジンとロフェキシジンの有効性を比較する.
- 試験中に遭遇した非科学的な障壁を特定し,記録する.
主な方法:
- ダブルブラインドで比較的な臨床試験の設計です.
- オピオイド離脱症候群を患っている患者を含む.
- 症状管理のためにクロニジンとロフェキシジンの投与.
主要な成果:
- 試験は,多くの非科学的な障害のために早めに終了されました.
- 課題には,研究ベッドの可用性,患者の自己退院,スタッフの態度,そして物流上の問題が含まれていました.
- ロフェキシジンの商用停止と資金の撤回も,終了に寄与した.
結論:
- 非科学的な要因は,試験の進行と完了に大きな影響を与えました.
- この研究は,外的,非科学的な変数に対する臨床研究の脆弱性を強調しています.
- OWS治療に関するさらなる研究は,このような実用的な課題を軽減するために,堅実な計画が必要です.
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