Trial Outcomes & Findings for Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone (NCT NCT01395784)

Results Overview

Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

32 participants

Primary outcome timeframe

Measured during the lab session conducted at the end of each maintenance period

Results posted on

2016-02-23

Participant milestones
Measure	Withing-subjects, Placebo-Controlled Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg. pioglitazone: A PPARγ agonist, also marketed as Actos.
Overall Study STARTED	32
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	15

Reasons for withdrawal
Measure	Withing-subjects, Placebo-Controlled Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg. pioglitazone: A PPARγ agonist, also marketed as Actos.
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	5

Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone

Baseline characteristics by cohort
Measure	Withing-subjects, Placebo-Controlled n=17 Participants Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

Timeframe: Measured during the lab session conducted at the end of each maintenance period

Population: Shown below are peak drug effects from each of the 3 maintenance periods (Placebo, Pioglitazone (PIO) 15, and PIO 45)

Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)

Outcome measures
Measure	All Participants n=17 Participants Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
Subjective Ratings of "Good" Drug Effect Placebo	37 units on a scale Standard Deviation 12
Subjective Ratings of "Good" Drug Effect PIO 15	35 units on a scale Standard Deviation 9
Subjective Ratings of "Good" Drug Effect PIO 45	35 units on a scale Standard Deviation 11

Timeframe: Measured during the lab session conducted at the end of each maintenance period

Latency to withdraw hand from cold water during the cold pressor test.

Outcome measures
Measure	All Participants n=17 Participants Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
Analgesic Responses Using the Cold Pressor Test Placebo	110 seconds Standard Deviation 23
Analgesic Responses Using the Cold Pressor Test PIO 15	71 seconds Standard Deviation 8
Analgesic Responses Using the Cold Pressor Test PIO 45	75 seconds Standard Deviation 10

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

New York State Psychiatric Institute

Phone: 646 774-6113