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

This study has been completed.
Sponsor:
Collaborator:
Omeros Corporation
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01395784
First received: July 13, 2011
Last updated: January 26, 2016
Last verified: November 2013
  Purpose
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.

Condition Intervention Phase
Opioid Abuse
Drug: pioglitazone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Subjective Ratings of "Good" Drug Effect [ Time Frame: Measured during the lab session conducted at the end of each maintenance period ] [ Designated as safety issue: No ]
    Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)


Secondary Outcome Measures:
  • Analgesic Responses Using the Cold Pressor Test [ Time Frame: Measured during the lab session conducted at the end of each maintenance period ] [ Designated as safety issue: No ]
    Latency to withdraw hand from cold water during the cold pressor test.


Enrollment: 32
Study Start Date: August 2010
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Actos

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

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395784

Locations
United States, New York
Columbia Univ/ NYSPI Division on Substance Abuse
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Omeros Corporation
Investigators
Principal Investigator: Sandra D Comer, MD Columbia University
  More Information

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01395784     History of Changes
Other Study ID Numbers: 6106  R01DA09236 
Study First Received: July 13, 2011
Results First Received: August 31, 2015
Last Updated: January 26, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Data has been presented at conferences and being prepared for a peer-review publication.

Keywords provided by New York State Psychiatric Institute:
Oxycodone
Opioid abuse

Additional relevant MeSH terms:
Pioglitazone
Oxycodone
Hypoglycemic Agents
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 25, 2016