A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted
2017년 4월 17일 업데이트: Pfizer
A Randomized, Double-blind, Placebo Controlled, Single-dose, 4-way Crossover Study To Determine The Relative Abuse Potential Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride Extended Release Capsules) Compared To Oxycodone Immediate Release, And Placebo When Administered Intranasally To Non-dependent, Recreational Opioid Users.
The main purpose of this study is to determine if oxycodone and naltrexone combination capsules (ALO-02) have the potential to be abused when they are crushed and snorted.
연구 개요
상태
완전한
정황
상세 설명
Abuse Liability Study
연구 유형
중재적
등록 (실제)
45
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5V 2T3
- INC Research Toronto Inc.
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Healthy subjects
- Non-dependent, recreational opioid users. (Must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before Visit 1 (Screening Visit).
- Must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before Visit 1 (Screening Visit).
Exclusion Criteria:
- Diagnosis of substance and/or alcohol dependence
- Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 트리트먼트 B
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crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
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위약 비교기: 트리트먼트 C
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crushed lactose tablets (powder) x 1 dose
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활성 비교기: 트리트먼트 D
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Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
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위약 비교기: 트리트먼트 A
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crushed sugar spheres (powder) x 1 dose
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Drug Liking: Peak Effect (Emax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm).
Peak Effect (Emax) = Maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Drug Liking: Area Under Effect Curve (AUE) From 0-2 Hour
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
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Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 millimeter (mm) bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the extreme left with "strong disliking" (score of 0 mm) and on the extreme right with "strong liking" (score of 100 mm).
AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
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High: Peak Effect (Emax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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High: Area Under Effect Curve (AUE) From 0-2 Hour
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
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High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-2) = Area under the effect versus time curve from time 0 to 2 hours.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2 hours post-dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Take Drug Again: Peak Effect (Emax)
기간: Intervention period: 12, 24 hours post-dose
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Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity.
It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
Emax = Maximum observed score.
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Intervention period: 12, 24 hours post-dose
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Take Drug Again: Mean Effect (Emean)
기간: Intervention period: 12, 24 hours post-dose
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Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity.
It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
Emean = Average observed score.
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Intervention period: 12, 24 hours post-dose
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Take Drug Again Effect at Hours 12 and 24
기간: Intervention period: 12, 24 hours post-dose
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Take drug again VAS is a subjective assessment of the degree to which a participant would desire to take the drug again if given the opportunity.
It is presented on a 100 mm VAS with score ranging from 0 mm to 100 mm (score of 0 mm = "definitely would not", 50 mm = "do not care", and 100 mm = "definitely would").
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Intervention period: 12, 24 hours post-dose
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Overall Drug Liking: Peak Effect (Emax)
기간: Intervention period: 12, 24 hours post-dose
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Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects).
A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking").
Emax = Maximum observed score.
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Intervention period: 12, 24 hours post-dose
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Overall Drug Liking: Mean Effect (Emean)
기간: Intervention period: 12, 24 hours post-dose
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Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects).
A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking").
Emean = Average observed score.
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Intervention period: 12, 24 hours post-dose
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Overall Drug Liking Effect at Hours 12 and 24
기간: Intervention period: 12, 24 hours post-dose
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Overall drug liking VAS assesses the participant's global perception of drug liking (that is, effects over the whole course of the drug experience including any carry-over effects).
A 100 mm VAS is used to assess response based on a score ranging from 0 mm to 100 mm (0 mm = "strong disliking", 50 mm = "neither like nor dislike", and 100 mm= "strong liking").
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Intervention period: 12, 24 hours post-dose
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Any Drug Effects: Peak Effect (Emax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Any Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Any Drug Effects: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Any Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Good Drug Effects: Peak Effect (Emax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Good Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Good Drug Effects: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Good Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Bad Drug Effects: Peak Effect (Emax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Bad Drug Effects: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Bad Drug Effects: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Bad Drug Effects VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Feel Sick: Peak Effect (Emax)
기간: Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention periods: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Feel Sick: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Feel Sick: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Feel Sick VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Nausea: Peak Effect (Emax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Nausea: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Nausea: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Nausea VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Sleepy: Peak Effect (Emax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Sleepy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Sleepy: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Sleepy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Dizzy: Peak Effect (Emax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
Emax = Maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Dizzy: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Dizzy: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Dizzy VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from a response of 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
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Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Percentage of Dose (Drug Powder) Insufflated
기간: Intervention period: 0 Hour post-dose
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The percentage of dose insufflated, was based on a calculation of the weight of powder remaining (if any) following each dosing during the intervention period.
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Intervention period: 0 Hour post-dose
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Pupillometry: Peak Effect (Emax)
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
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Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties.
Participants have the size of pupil measured using a pupillometer.
Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
The same eye for each participant was used for all measurements during the study.
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
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Pupillometry: Area Under Effect Curve (AUE) From 0-1 Hour, 0-2 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties.
Participants have the size of pupil measured using a pupillometer.
Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
The same eye for each participant was used for all measurements during the study.
AUE (0-x) = Area under the effect versus time curve from time zero to time of last quantifiable effect (0-x).
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Pupillometry: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Pupillometry assessments measure change in pupil size (miosis) as an indicator of opioid pharmacological properties.
Participants have the size of pupil measured using a pupillometer.
Measurements are made in a dimly lit (mesopic) room with controlled lighting conditions.
The same eye for each participant was used for all measurements during the study.
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Drug Liking: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hour
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Drug Liking: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Drug liking assesses the degree that a participant likes a drug effect at the time the question is being asked (that is, at the moment).
It is scored using a 100 mm bipolar VAS anchored in the center with a neutral anchor of "neither like nor dislike" (score of 50 mm), on the left with "strong disliking" (score of 0 mm) and on the right with "strong liking" (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
High: Area Under Effect Curve (AUE) From 0-1 Hour, 0-8 Hour and 0-24 Hours
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
High: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
High VAS assesses the effect experienced by the participant on a 100 mm unipolar VAS, where responses are unidirectional and range from 'none' (score of 0 mm) to 'extremely' (score of 100 mm).
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Subject Rating Scale for Nasal Effects: Peak Effect (Emax)
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be").
Emax = Maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
|
Subject Rating Scale for Nasal Effects: Area Under Effect Curve (AUE) From 0-1 Hour and 0-2 Hour
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be").
AUE (0-x) = Area under the effect versus time curve from time 0 to x hours (0-x).
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
|
Subject Rating Scale for Nasal Effects: Time to Maximum (Peak) Effect (TEmax)
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
Participant-rated scale for nasal effects was used to assess burning, need to blow nose, runny nose/nasal discharge, facial pain/pressure, and nasal congestion using a 6-point scale (where, 0 = not present/no problem; 1 = very mild problem; 2 = mild/slight problem; 3 = moderate problem; 4 = severe problem; 5 = problem "as bad as can be").
TEmax = Time to maximum observed score.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax) of Oxycodone, Oxymorphone and Noroxycodone
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Maximum Observed Plasma Concentration (Cmax) of Naltrexone and 6-beta-naltrexol
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Oxycodone, Oxymorphone and Noroxycodone
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Naltrexone and 6-beta-naltrexol
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Plasma Decay Half-Life (t1/2) of Oxycodone, Oxymorphone and Noroxycodone
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Plasma Decay Half-Life (t1/2) of Naltrexone and 6-beta-naltrexol
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Oxycodone, Oxymorphone and Noroxycodone
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
AUC is a measure of the serum concentration of the drug over time.
It is used to characterize drug absorption.
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Oxycodone, Oxymorphone and Noroxycodone
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast).
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Oxycodone, Oxymorphone and Noroxycodone
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
It is obtained from AUC (0 - t) plus AUC (t - ∞).
Participants who received oxycodone and ALO-02 were reported.
Oxymorphone and noroxycodone are metabolites of oxycodone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Area Under the Concentration-Time Curve (AUC) From 0-1 Hour, 0-2 Hour and 0-8 Hour of Naltrexone and 6-beta-naltrexol
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
AUC is a measure of the serum concentration of the drug over time.
It is used to characterize drug absorption.
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 hours post-dose
|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Naltrexone and 6-beta-naltrexol
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
Area under the plasma concentration time-curve from zero to the last quantifiable concentration (AUClast).
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Naltrexone and 6-beta-naltrexol
기간: Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞).
It is obtained from AUC (0 - t) plus AUC (t - ∞).
Participants who received ALO-02 were reported.
6-Beta-naltrexol is metabolites of naltrexone.
|
Intervention period: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
기간: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship.
SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 3 - 7 days following last study drug administration that were absent before treatment or that worsened relative to pre-treatment state.
Symptoms of withdrawal following naloxone administration (naloxone challenge phase) were not collected as adverse events unless they met the criteria for an SAE.
AEs included SAEs as well as non-serious AEs which occurred during the trial.
|
Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
|
Number of Participants With Clinically Significant Change in Vital Sign Examinations
기간: Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
Vital signs assessment included measurement of heart rate, systolic and diastolic blood pressures, and respiratory rate.
Criteria for clinically significant change in any vital sign examination was based on investigator's discretion.
|
Screening up to 3 to 7 days following last study drug administration, or time of early withdrawal
|
|
Number of Participants With Clinically Significant Change in End Tidal Carbon Dioxide (EtCO2)
기간: Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
End-tidal carbon dioxide concentration in the expired air (EtCO2) was monitored using capnography in a sitting position.
Criteria for clinically significant change in EtCO2 was based on investigator's discretion.
|
Intervention period: pre-dose, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose
|
|
Number of Participants With Clinically Significant Change in Oxygen Saturation of Hemoglobin (SpO2)
기간: Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours
|
Oxygen saturation of hemoglobin in blood (SpO2) was monitored using pulse oximetry continuously for 5 hours following dosing in the drug discrimination phase and continuously for 12 hours following dosing in the treatment phase, or longer at the discretion of the investigator.
Individual measurement was collected in a sitting position.
If SpO2 fall below 90 percent (%), the investigator administered oxygen via nasal cannula at a flow rate sufficient to maintain the SpO2 greater than or equal to 90%.
Participants with fall in SpO2 below 90% were reported.
|
Drug discrimination phase: pre-dose up to 5 hours; intervention period: pre-dose up to 12 hours
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
협력자
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2013년 2월 1일
기본 완료 (실제)
2013년 7월 1일
연구 완료 (실제)
2013년 7월 1일
연구 등록 날짜
최초 제출
2013년 1월 22일
QC 기준을 충족하는 최초 제출
2013년 1월 22일
처음 게시됨 (추정)
2013년 1월 24일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 7월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 4월 17일
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- B4531009
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