Subjective Analgesic Effects of Naloxone and Virtual Reality (Narcan)
This study is designed to test a specific hypothesis exploring the neurophysiologic mechanism(s) that underlie the pain- relieving effects of immersive Virtual Reality (VR) as a non-pharmacologic pain management technique, using healthy volunteers experiencing carefully controlled thermal and/or electrical pain in the laboratory. Over the past decade, our research group has performed a series of NIH-funded investigations of VR analgesia - in both the clinical pain and laboratory pain settings - demonstrating its clinical efficacy and safety. In the current study we will test pharmacologic manipulation of VR analgesia (with the opioid analgesia antagonist naloxone). We anticipate that this theoretical work will provide a foundation for future clinical applications of immersive VR - whether used alone or in combination with other analgesic agents - and make immersive VR a more effective and more widely used analgesic tool for the treatment of clinical pain.
Our previous work with immersive VR indicates that its use during a painful event can reduce subjective pain reports during both acute clinical and laboratory pain by 20-50% [1]. Furthermore, we have shown that effective VR analgesia is associated with reduced pain-related brain activity that is quantitatively and qualitatively comparable to clinically relevant doses of systemic opioid analgesics [2]. The laboratory pain protocol proposed in the current application is identical to the UW HSD-approved protocol used in our previous studies (#25296 - "Reducing Brief Thermal and Electrical Pain"). What is specifically different in the current protocol is the use of naloxone to determine whether VR analgesia operates through an endogenous opioid-dependent mechanism or not. The results of this study will not only suggest the mechanism of action of VR analgesia, but also allow us to more effectively apply immersive VR analgesia in the clinically pain setting through its thoughtful combination with well-established pharmacologic analgesic techniques, such as opioid analgesia administration.
The specific aim of this study and the hypothesis it tests are as follows: To determine the extent to which subjective analgesic effects of VR analgesia are inhibited by opioid receptor antagonism with naloxone. Hypothesis - VR analgesia will not be inhibited by systemic opioid receptor antagonism, suggesting that VR analgesia is not mediated by release of endogenous opiates and/or by activation of opioid-dependent descending central nervous system pathways.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Washington
-
Seattle、Washington、アメリカ、98195
- University of Washington Medical Center
-
-
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:
- Healthy males and females between the ages of 18 and 60 years
- Ability to communicate orally
- Body mass index of 30 or less
Exclusion Criteria:
- Women who are pregnant, trying to become pregnant or who are breastfeeding.
- History of alcohol or substance abuse
- Major medical illness, including history or migraine headaches
- Allergy or sensitivity to narcotics or naloxone
- Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids
- Predisposition to severe motion sickness
- Unusual sensitivity or lack of sensitivity to pain
- Sensitive skin
- Urine toxicology positive for opioids
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:支持療法
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:ダブル
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:naloxone
4 mg in 10 ml saline iv bolus
|
4 mg naloxone in 10 ml saline given iv bolus
他の名前:
|
|
プラセボコンパレーター:saline placebo
10 ml of normal saline iv bolus
|
10 ml of normal saline iv bolus
|
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 |
時間枠 |
|---|---|
|
Pain scoring from sessions where naloxone is given or placebo.Pain scoring is a questionnaire using analog scale (1-10).
時間枠:Outcome measurements will be assessed when all research and analysis has been completed. We project the approximate time frame to be about 18 months.
|
Outcome measurements will be assessed when all research and analysis has been completed. We project the approximate time frame to be about 18 months.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Samuel R Sharar, MD、University of Washington
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。