Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
The ability of pioglitazone (PIO) to alter the effects of opioids in humans has not been characterized in a controlled laboratory setting. Accordingly, the proposed investigation seeks to examine the effects of PIO on oxycodone, one of the most commonly used and abused opioid drugs in the U.S. (Davis et al., 2003). More specifically, the primary aim of this investigation is to characterize the subjective effects of oxycodone under maintenance on various doses of PIO (0, 15, and 45 mg) in non-dependent, prescription opioid abusers. Secondary aims of the study are to examine the influence of PIO on the analgesic, cognitive, and physiological effects of oxycodone.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone|
- Subjective ratings of drug, mood, and physiological effects [ Time Frame: Repeatedly during the 9-week study ] [ Designated as safety issue: No ]Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)
- Analgesic responses using the cold pressor test [ Time Frame: Repeatedly over the 9-week study ] [ Designated as safety issue: No ]Latency to first feel pain (in sec) and latency to remove the hand from the water (in sec) are the primary analgesic endpoints.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: Withing-subjects, Placebo-Controlled||
A PPARγ agonist, also marketed as Actos.
Other Name: Actos
This 9-week investigation will use an inpatient/outpatient design in which participants (N=20 completers) will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on 15 mg followed by 3 weeks on 45 mg). For each dose, 2 weeks of stabilization will occur on an outpatient basis, followed by a one-week inpatient stay. During the inpatient stay, the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01395784
|United States, New York|
|Columbia Univ/ NYSPI Division on Substance Abuse||Recruiting|
|New York, New York, United States, 10032|
|Contact: Gabriela Madera, B.A 212-543-5153|
|Contact: Phil Saccone, B.A 212 543-6206|
|Principal Investigator: Sandra Comer, Ph.D|
|Principal Investigator:||Sandra D Comer, MD||Columbia University|