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Completed

NCT Number: NCT01395784

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.

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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia Univ/ NYSPI Division on Substance Abuse

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recreational use of prescription opioids at least once per month within the past year
  • No current major mood, psychotic, or anxiety disorder
  • Physically healthy
  • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) within normal limits
  • 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

  • Physical dependence on any drugs, excluding nicotine and caffeine
  • Participants requesting treatment
  • Participants on parole or probation
  • 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)
  • Current or recent history of significant violent behavior (within the past 6 months)
  • Current major Axis I psychopathology that might interfere with ability to participate in the study
  • Significant suicide risk
  • Current chronic pain
  • Current or history of congestive heart failure, edema, or diabetes mellitus
  • Sensitivity, allergy, or contraindication to opioids or pioglitazone
  • 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)

Treatment and study plan

pioglitazone

Drug

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.

Other names: Actos

Primary outcomes

  1. Subjective Ratings of "Good" Drug Effect

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

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

Secondary outcomes

  1. Analgesic Responses Using the Cold Pressor Test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Omeros Corporation

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2011
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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