Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone

January 26, 2016 updated by: New York State Psychiatric Institute
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia Univ/ NYSPI Division on Substance Abuse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Maintenance Period
Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB).
Drug: pioglitazone
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
Experimental: PIO 15 Maintenance Period
Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg.
Drug: pioglitazone
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
Experimental: PIO 45 Maintenance Period
Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.
Drug: pioglitazone
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Measured during the lab session conducted at the end of each maintenance period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured during the lab session conducted at the end of each maintenance period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

Omeros Corporation

Investigators

  • Principal Investigator: Sandra D Comer, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

July 13, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 18, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6106
  • R01DA09236 (Other Identifier: NIH Grant Award Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data has been presented at conferences and being prepared for a peer-review publication.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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