Trial Outcomes & Findings for Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users (NCT NCT01030406)
NCT ID: NCT01030406
Last Updated: 2018-11-01
Results Overview
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Measure collected at 0.5 hours post-dose
Results posted on
2018-11-01
Participant Flow
Participant milestones
| Measure |
40/0mg Taken First
Ocycodone/Naicin 40/0mg Tablets
|
80/0mg Taken First
Oxycodone/Niacin 80/0mg tablets
|
40/240mg Taken First
Oxycodone?Niacin 40/240mg tablets
|
80/480mg Taken First
Oxycodone/Naicin 80/480mg
|
0/0mg Taken First
Placebo: Tablets
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
10
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 drop out; 1 protocol violation
Baseline characteristics by cohort
| Measure |
40/0mg Taken First
n=10 Participants
oxycodone.naicin 40/0mg tablets
|
80/0mg Taken First
n=10 Participants
oxycodone.naicin 80/0mg tablets
|
40/240mg Taken First
n=9 Participants
oxycodone.naicin 40/240mg tablets
|
80/480mg Taken First
n=9 Participants
oxycodone.naicin 80/480mg tablets
|
0/0mg Taken First
n=9 Participants
Placebo Tablets
|
Total
n=47 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
47 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
|
23.9 years
STANDARD_DEVIATION 4.83 • n=5 Participants • 2 drop out; 1 protocol violation
|
23.9 years
STANDARD_DEVIATION 4.83 • n=7 Participants • 2 drop out; 1 protocol violation
|
23.9 years
STANDARD_DEVIATION 4.83 • n=5 Participants • 2 drop out; 1 protocol violation
|
23.9 years
STANDARD_DEVIATION 4.83 • n=4 Participants • 2 drop out; 1 protocol violation
|
23.9 years
STANDARD_DEVIATION 4.83 • n=21 Participants • 2 drop out; 1 protocol violation
|
23.9 years
STANDARD_DEVIATION 4.83 • n=8 Participants • 2 drop out; 1 protocol violation
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
9 participants
n=4 Participants
|
9 participants
n=21 Participants
|
47 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Measure collected at 0.5 hours post-dosePopulation: Per protocol completers
Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).
Outcome measures
| Measure |
40/0mg
n=46 Participants
8x Oxycodone/Naicin 5/0mg tablets
|
80/0mg
n=46 Participants
8x Oxycodone/Naicin 10/0mg tablets
|
40/240mg
n=46 Participants
8x Oxycodone/Naicin 5/30mg tablets
|
80/480mg
n=46 Participants
8x Oxycodone/Naicin 10/60mg tablets
|
0/0mg
n=46 Participants
Placebo: Tablets
|
|---|---|---|---|---|---|
|
Drug Liking at .5 Hours
|
66.0 score on a scale
Standard Deviation 16.44
|
74.7 score on a scale
Standard Deviation 16.86
|
47.7 score on a scale
Standard Deviation 19.96
|
40.9 score on a scale
Standard Deviation 22.93
|
50.3 score on a scale
Standard Deviation 2.28
|
Adverse Events
40/0mg
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
80/0mg
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
40/240mg
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
80/480ng
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
0/0mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
40/0mg
n=49 participants at risk
Oxycodone hcl 40mg
|
80/0mg
n=49 participants at risk
Oxycodone hcl 40mg
|
40/240mg
n=49 participants at risk
Oxycodone hcl 40mg/niacin 240mg
|
80/480ng
n=49 participants at risk
Oxycodone hcl 80mg/niacin 480mg
|
0/0mg
n=49 participants at risk
Placebo: Tablets
|
|---|---|---|---|---|---|
|
Vascular disorders
Flushing
|
0.00%
0/49
|
6.1%
3/49 • Number of events 3
|
87.8%
43/49 • Number of events 43
|
93.9%
46/49 • Number of events 46
|
0.00%
0/49
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
59.2%
29/49 • Number of events 29
|
69.4%
34/49 • Number of events 34
|
73.5%
36/49 • Number of events 36
|
79.6%
39/49 • Number of events 39
|
4.1%
2/49 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
34.7%
17/49 • Number of events 17
|
36.7%
18/49 • Number of events 18
|
26.5%
13/49 • Number of events 13
|
44.9%
22/49 • Number of events 22
|
2.0%
1/49 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • Number of events 2
|
12.2%
6/49 • Number of events 6
|
6.1%
3/49 • Number of events 3
|
12.2%
6/49 • Number of events 6
|
0.00%
0/49
|
|
Gastrointestinal disorders
nausea
|
8.2%
4/49 • Number of events 4
|
36.7%
18/49 • Number of events 18
|
10.2%
5/49 • Number of events 5
|
34.7%
17/49 • Number of events 17
|
0.00%
0/49
|
|
Gastrointestinal disorders
vomiting
|
2.0%
1/49 • Number of events 1
|
22.4%
11/49 • Number of events 11
|
8.2%
4/49 • Number of events 4
|
16.3%
8/49 • Number of events 8
|
0.00%
0/49
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place