Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Condition: Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: pioglitazone
Intervention description: A 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.
Intervention MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 32.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Oxycodone; Opioid abuse

Summary:

      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.
    

Eligibility criteria:

        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)