Trial Outcomes & Findings for Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users (NCT NCT01759446)
NCT ID: NCT01759446
Last Updated: 2018-11-01
Results Overview
"Do you dislike or like the drug effect you are feeling now?" The question is scored using a 100-point bipolar visual analog scale (VAS) anchored in the center with "neither like nor dislike" (score of 50), on the left with "Strong Disliking" (score of 0) and on the right with "Strong Liking" (score of 100). Maximum Score. Assessment were made at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
8 hours
Results posted on
2018-11-01
Participant Flow
44 recreational drug users with snorting experience were enrolled with 40 completing-Crossover designed
Each subject had to pass a blinded snorted drug discrimination phase to meet enrollment.
Participant milestones
| Measure |
Placebo Taken First
followed by all other drugs with 48 hours washout in between
|
Generic H/A Taken First
followed by all other drugs with 48 hours washout in between
|
Vycavert Taken First
followed by all other drugs with 48 hours washout in between
|
Generic H/A Plus i Taken First
followed by all other drugs with 48 hours washout in between
|
Generic H/A Plus p Taken First
followed by all other drugs with 48 hours washout in between
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo Taken First
followed by all other drugs with 48 hours washout in between
|
Generic H/A Taken First
followed by all other drugs with 48 hours washout in between
|
Vycavert Taken First
followed by all other drugs with 48 hours washout in between
|
Generic H/A Plus i Taken First
followed by all other drugs with 48 hours washout in between
|
Generic H/A Plus p Taken First
followed by all other drugs with 48 hours washout in between
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
Baseline characteristics by cohort
| Measure |
Placebo Taken First
n=8 Participants
followed by all other doses crossover
|
Generic H/A Taken First
n=8 Participants
followed by all other doses crossover
|
Vycavert Taken First
n=8 Participants
followed by all other doses crossover
|
Generic H/A Plus i Taken First
n=8 Participants
followed by all other doses crossover
|
Generic H/A Plus p Taken First
n=8 Participants
followed by all other doses crossover
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 3.99 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 3.99 • n=7 Participants
|
24.4 years
STANDARD_DEVIATION 3.99 • n=5 Participants
|
24.4 years
STANDARD_DEVIATION 3.99 • n=4 Participants
|
24.4 years
STANDARD_DEVIATION 3.99 • n=21 Participants
|
24.4 years
STANDARD_DEVIATION 3.99 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
8 participants
n=21 Participants
|
40 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 8 hoursPopulation: Completers of all doses per protocol
"Do you dislike or like the drug effect you are feeling now?" The question is scored using a 100-point bipolar visual analog scale (VAS) anchored in the center with "neither like nor dislike" (score of 50), on the left with "Strong Disliking" (score of 0) and on the right with "Strong Liking" (score of 100). Maximum Score. Assessment were made at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, and 8 hours post-dosing.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo
|
Generic H/A
n=40 Participants
Hydrocodone and Acetaminophen
|
Vycavert
n=40 Participants
hydrocodone and acetaminophen
|
Generic H/A Plus i
n=40 Participants
Hydrocodone/Acetaminophen with selected inactives
|
Generic H/A Plus p
n=40 Participants
Hydrocodone/Acetaminophen plus placebo
|
|---|---|---|---|---|---|
|
Emax - Maximum Drug Liking
|
54.5 score on a scale
Standard Deviation 8.52
|
75.0 score on a scale
Standard Deviation 11.81
|
72.1 score on a scale
Standard Deviation 12.98
|
75.6 score on a scale
Standard Deviation 12.48
|
73.0 score on a scale
Standard Deviation 13.13
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Generic H/A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Vycavert
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Generic H/A Plus i
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Generic H/A Plus p
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=44 participants at risk
Placebo
|
Generic H/A
n=44 participants at risk
Hydrocodone and Acetaminophen
|
Vycavert
n=44 participants at risk
hydrocodone and acetaminophen
|
Generic H/A Plus i
n=44 participants at risk
Hydrocodone/Acetaminophen with selected inactives
|
Generic H/A Plus p
n=44 participants at risk
Hydrocodone/Acetaminophen plus placebo
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Burning in throat
|
0.00%
0/44 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
0.00%
0/44 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
13.6%
6/44 • Number of events 6 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
22.7%
10/44 • Number of events 10 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
6.8%
3/44 • Number of events 3 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Burning
|
4.5%
2/44 • Number of events 2 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
11.4%
5/44 • Number of events 5 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
29.5%
13/44 • Number of events 13 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
40.9%
18/44 • Number of events 18 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
9.1%
4/44 • Number of events 4 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/44 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
2.3%
1/44 • Number of events 1 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
0.00%
0/44 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
2.3%
1/44 • Number of events 1 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
6.8%
3/44 • Number of events 3 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
6.8%
3/44 • Number of events 3 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
9.1%
4/44 • Number of events 4 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
4.5%
2/44 • Number of events 2 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
4.5%
2/44 • Number of events 2 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Number of events 1 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
2.3%
1/44 • Number of events 1 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
11.4%
5/44 • Number of events 5 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
4.5%
2/44 • Number of events 2 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
0.00%
0/44 • AE's were collected as observed at systemically at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5 and 24 hours post-dose. AE's were observed and reported from first dose through the end of study (11 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place