Trial Outcomes & Findings for Aprepitant Effects on Oxycodone Response (NCT NCT00999544)

NCT ID: NCT00999544

Last Updated: 2017-09-01

Results Overview

Visual analog scale ratings (from 0-100) on the subject-rated measure of "How much do you like the drug?" with higher scores indicating greater abuse liability (and 100 anchored with "extremely" and zero indicating none anchored with "none at all." Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 42 days
• Results posted on: 2017-09-01

Participant Flow

All recruitment was conducted through a research clinic at a public university.

Subjects were initially screened for inclusion/exclusion criteria. Fifteen subjects signed the screening consent but only nine were qualified to participate and signed the study consent. One subject left the study before receiving any interventions.

Participant milestones

Measure	Within-subject Crossover Design All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Within-subject Crossover Design All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Aprepitant Effects on Oxycodone Response

Baseline characteristics by cohort

Measure	Crossover Within Subject n=9 Participants All subjects were exposed to every condition.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.3 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days

Population: Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges. The within subject data analysis does not lend itself to reporting data in the format provided below.

Visual analog scale ratings (from 0-100) on the subject-rated measure of "How much do you like the drug?" with higher scores indicating greater abuse liability (and 100 anchored with "extremely" and zero indicating none anchored with "none at all." Data were collected across multiple time points but the peak maximum score was used for the primary outcome measure.

Outcome measures

Measure	Placebo-Placebo (in and po) n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg - Placebo n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg- Placebo n=8 Participants All subjects received exposure to this study condition once.	Placebo- 15 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Placebo- 30 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Placebo- 20 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Placebo - 40 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg- 15 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg - 30 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg- 20 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg - 40 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg - 15 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg - 30 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg- 20 Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg- 40 Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.
Abuse Liability Proxy	0.197 units on a scale (points 0-100) Standard Deviation 0.197	0.483 units on a scale (points 0-100) Standard Deviation 0.397	0.159 units on a scale (points 0-100) Standard Deviation 0.159	7.678 units on a scale (points 0-100) Standard Deviation 2.656	17.450 units on a scale (points 0-100) Standard Deviation 4.275	9.850 units on a scale (points 0-100) Standard Deviation 5.090	16.646 units on a scale (points 0-100) Standard Deviation 4.203	8.543 units on a scale (points 0-100) Standard Deviation 2.892	15.092 units on a scale (points 0-100) Standard Deviation 4.706	13.281 units on a scale (points 0-100) Standard Deviation 4.009	17.244 units on a scale (points 0-100) Standard Deviation 4.788	17.195 units on a scale (points 0-100) Standard Deviation 4.897	28.211 units on a scale (points 0-100) Standard Deviation 4.365	8.196 units on a scale (points 0-100) Standard Deviation 2.667	26.322 units on a scale (points 0-100) Standard Deviation 3.702

SECONDARY outcome

Timeframe: 42 days

Population: Prior laboratory-based within subject studies of the pharmacodynamic response to opioid challenges.

Respiration rate measured over 60 seconds. Data were collected across multiple time points, but the peak minimum score was used for this outcome measure.

Outcome measures

Measure	Placebo-Placebo (in and po) n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg - Placebo n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg- Placebo n=8 Participants All subjects received exposure to this study condition once.	Placebo- 15 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Placebo- 30 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Placebo- 20 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Placebo - 40 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg- 15 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg - 30 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg- 20 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 40 mg - 40 mg Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg - 15 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg - 30 mg Oxycodone Intranasal n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg- 20 Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.	Aprepitant 200 mg- 40 Oxycodone Oral n=8 Participants All subjects received exposure to this study condition once.
Respiration Depression	13.75 number of breaths per minute Standard Deviation 3.15	11.63 number of breaths per minute Standard Deviation 1.60	11.25 number of breaths per minute Standard Deviation 1.75	12.13 number of breaths per minute Standard Deviation 2.30	10.25 number of breaths per minute Standard Deviation 1.98	12.25 number of breaths per minute Standard Deviation 2.19	12.25 number of breaths per minute Standard Deviation 2.12	11.00 number of breaths per minute Standard Deviation 2.33	12.38 number of breaths per minute Standard Deviation 1.92	11.63 number of breaths per minute Standard Deviation 2.56	14.00 number of breaths per minute Standard Deviation 2.33	14.00 number of breaths per minute Standard Deviation 2.33	12.13 number of breaths per minute Standard Deviation 2.17	12.00 number of breaths per minute Standard Deviation 1.93	11.38 number of breaths per minute Standard Deviation 3.02

Adverse Events

Within-subject Crossover Design

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sharon Walsh

University of Kentucky

Phone: 859-257-6485

Email: sharon.walsh@uky.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place