Opioid Abuse | Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Opioid Abuse research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Recreational use of prescription opioids at least once per month within the past year 2. No current major mood, psychotic, or anxiety disorder 3. Physically healthy 4. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) within normal limits 5. Able to perform study procedures 6.21-45 years of age 7.Blood glucose concentration between 70-145 mg/dl for men and 70-125 mg/dl for women (fasting) 8.Hb > 13 for men and Hb > 11 for women with no other evidence of medical disorder resulting in blood loss or anemia/hematological disease Exclusion Criteria: 1. Physical dependence on any drugs, excluding nicotine and caffeine 2. Participants requesting treatment 3. Participants on parole or probation 4. Pregnancy or lactation: Female participants must agree to the use of a barrier control method of contraception (e.g. male and female condoms, diaphragms, cervical caps and contraceptive sponges used in combination with spermicide) 5. Current or recent history of significant violent behavior (within the past 6 months) 6. Current major Axis I psychopathology that might interfere with ability to participate in the study 7. Significant suicide risk 8. Current chronic pain 9. Current or history of congestive heart failure, edema, or diabetes mellitus 10. Sensitivity, allergy, or contraindication to opioids or pioglitazone 11. Unstable physical disorders that might make participation hazardous, such as end-stage AIDS, hypertension (blood pressure > 140/90), or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:pioglitazoneA PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo Maintenance PeriodParticipants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB).
PIO 15 Maintenance PeriodParticipants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg.
PIO 45 Maintenance PeriodParticipants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.
Start Date: August 2010
Completed Date: April 2014
Phase: Phase 2
Primary Outcome: Subjective Ratings of "Good" Drug Effect
Secondary Outcome: Analgesic Responses Using the Cold Pressor Test
Study sponsors, principal investigator, and references
Principal Investigator: Sandra D Comer, MD
Lead Sponsor: New York State Psychiatric Institute
Collaborator: Omeros Corporation