Clinical trial NCT01395784: Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Official title: Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid Abuse
Keywords: Oxycodone
Opioid abuse
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Omeros Corporation
First posted: 2011-07-18
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: This 9-week investigation will use an inpatient/outpatient design in which participants will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on PIO 15 mg followed by 3 weeks on PIO 45 mg). At the end of each maintenance period the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.

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)

Primary outcomes:
measure: Subjective Ratings of "Good" Drug Effect
timeFrame: Measured during the lab session conducted at the end of each maintenance period
Secondary outcomes:
measure: Analgesic Responses Using the Cold Pressor Test
timeFrame: Measured during the lab session conducted at the end of each maintenance period
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia Univ/ NYSPI Division on Substance Abuse
state: New York
Study officials:
affiliation: Columbia University
name: Sandra D Comer, MD
role: PRINCIPAL_INVESTIGATOR
References: