Trial Outcomes & Findings for Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers (NCT NCT01740414)

Results Overview

Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

42 days

Results posted on

2017-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	MN-166 First Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo.The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then Placebo).	Placebo First Patient began maintenance on placebo medication prior to switching to the active medication condition(MN-166). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo then MN-166).
Overall Study STARTED	12	16
Overall Study COMPLETED	3	8
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MN-166 (Formerly AV411) n=3 Participants Patient began maintenance on active medication first (MN-166, formerly AV411) prior to maintenance on placebo. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (MN-166, then placebo). Data are only from participants who completed both phases of the study.	Placebo n=8 Participants Patient began maintenance on placebo medication prior to maintenance active medication (MN-166, formerly AV411). The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo, then MN-166). Data are only from participants who completed both phases of the study.	Total n=11 Participants Total of all reporting groups
Age, Continuous	41.3 years STANDARD_DEVIATION 10.8 • n=5 Participants	49.5 years STANDARD_DEVIATION 1.7 • n=7 Participants	42.2 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	8 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days

Participants are allowed to perform an operant task (click on a mouse) in order to receive a dose drug under investigation (oxycodone dose 0 mg, 15 mg, or 30 mg). The drug breakpoint is the maximum number of responses (mouse clicks) the participant was willing to make to receive the drug. Within the context of abuse liability studies, larger breakpoints represent greater abuse potential of a drug.

Outcome measures

Outcome measures
Measure	MN-166 + Oxy 0 mg n=11 Participants The Effects of 0 mg of oxycodone while under MN-166 maintenance.	MN-166 + Oxy 15 mg n=11 Participants The Effects of 15 mg of oxycodone while under MN-166 maintenance.	MN-166 + Oxy 30 mg n=11 Participants The Effects of 30 mg of oxycodone while under MN-166 maintenance.	Placebo + Oxy 0 mg n=11 Participants The Effects of 0 mg of oxycodone while under placebo maintenance.	Placebo + Oxy 15 mg n=11 Participants The Effects of 15 mg of oxycodone while under placebo maintenance.	Placebo + Oxy 30 mg n=11 Participants The Effects of 30 mg of oxycodone while under placebo maintenance.
Drug Self-administration Breakpoint	347 Clicks on a computer mouse Standard Error 360	363 Clicks on a computer mouse Standard Error 180	1472 Clicks on a computer mouse Standard Error 763	43 Clicks on a computer mouse Standard Error 25	1650 Clicks on a computer mouse Standard Error 948	2459 Clicks on a computer mouse Standard Error 1184

SECONDARY outcome

Timeframe: 42 days

Participants are shown a 100-mm line and asked to indicate on that line the extent to which they agree with the descriptor of the drug effect such as "Liking/Liked the Drug." On this visual analog scale participants were instructed that the Left/ 0 mm point on the line represents "not at all," while the right/100 mm point represents "Extremely."

Outcome measures

Outcome measures
Measure	MN-166 + Oxy 0 mg n=11 Participants The Effects of 0 mg of oxycodone while under MN-166 maintenance.	MN-166 + Oxy 15 mg n=11 Participants The Effects of 15 mg of oxycodone while under MN-166 maintenance.	MN-166 + Oxy 30 mg n=11 Participants The Effects of 30 mg of oxycodone while under MN-166 maintenance.	Placebo + Oxy 0 mg n=11 Participants The Effects of 0 mg of oxycodone while under placebo maintenance.	Placebo + Oxy 15 mg n=11 Participants The Effects of 15 mg of oxycodone while under placebo maintenance.	Placebo + Oxy 30 mg n=11 Participants The Effects of 30 mg of oxycodone while under placebo maintenance.
Positive Subjective Effects to Oxycodone	.8 units on a scale Standard Deviation 5.6	10.9 units on a scale Standard Deviation 23.9	24.2 units on a scale Standard Deviation 35.1	.9 units on a scale Standard Deviation 3.4	15.5 units on a scale Standard Deviation 27.2	22.7 units on a scale Standard Deviation 36.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 42 days

15-item shortened form of the McGill Pain Questionnaire (Melzack, 1987) that is used to assess the sensory and affective dimensions of the pain experienced Participants describe their experience of pain by choosing among a series of possible answers (None \[score=1\], Mild \[score=2\], Moderate \[score=3\], or Severe \[score=4\]). They were asked to describe the pain as "Throbbing," "Shooting," "Stabbing," "Sharp," "Cramping," "Gnawing," "Hot-Burning," "Aching," "Heavy," "Tender," "Splitting," "Tired-Exhausting," "Sickening," "Fearful," and "Punishing-Cruel." Scores were added across all 15 items to generate a sum score, which ranged between 15 and 60.

Outcome measures

Outcome measures
Measure	MN-166 + Oxy 0 mg n=11 Participants The Effects of 0 mg of oxycodone while under MN-166 maintenance.	MN-166 + Oxy 15 mg n=11 Participants The Effects of 15 mg of oxycodone while under MN-166 maintenance.	MN-166 + Oxy 30 mg n=11 Participants The Effects of 30 mg of oxycodone while under MN-166 maintenance.	Placebo + Oxy 0 mg n=11 Participants The Effects of 0 mg of oxycodone while under placebo maintenance.	Placebo + Oxy 15 mg n=11 Participants The Effects of 15 mg of oxycodone while under placebo maintenance.	Placebo + Oxy 30 mg n=11 Participants The Effects of 30 mg of oxycodone while under placebo maintenance.
Pain Intensity	30 units on a scale Standard Error 3	25 units on a scale Standard Error 1	26 units on a scale Standard Error 2	31 units on a scale Standard Error 2	29 units on a scale Standard Error 2	27 units on a scale Standard Error 2

Adverse Events

MN-166 (Formerly AV411)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MN-166 (Formerly AV411) n=12 participants at risk Patient is receiving study drug (MN-166) first MN-166 (formerly AV411): in one study arm, 50mg MN-166 BID are administered daily for 20 days	Placebo n=16 participants at risk Patient is receiving placebo first. placebo: In the placebo arm, the patients receive placebo for 20 days
Nervous system disorders Insomnia	25.0% 3/12 • Number of events 8	43.8% 7/16 • Number of events 8
Gastrointestinal disorders GI Upset	16.7% 2/12 • Number of events 4	25.0% 4/16 • Number of events 9
Nervous system disorders Headache	0.00% 0/12	12.5% 2/16 • Number of events 3
Nervous system disorders Fatigue	0.00% 0/12	12.5% 2/16 • Number of events 5
Psychiatric disorders Depression	8.3% 1/12 • Number of events 3	0.00% 0/16
Nervous system disorders Back Ache	0.00% 0/12	6.2% 1/16 • Number of events 6

Additional Information

Dr. Sandra Comer

New York State Psychiatric Institute

Phone: 646-774-6146

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place