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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by New York State Psychiatric Institute
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: November 1, 2013
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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group 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 drug, mood, and physiological effects [ Time Frame: Repeatedly during the 9-week study ] [ 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: Repeatedly over the 9-week study ] [ Designated as safety issue: No ]
    Latency to first feel pain (in sec) and latency to remove the hand from the water (in sec) are the primary analgesic endpoints.


Estimated Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Withing-subjects, Placebo-Controlled Drug: pioglitazone
A PPARγ agonist, also marketed as Actos.
Other Name: Actos

Detailed Description:

This 9-week investigation will use an inpatient/outpatient design in which participants (N=20 completers) will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on 15 mg followed by 3 weeks on 45 mg). For each dose, 2 weeks of stabilization will occur on an outpatient basis, followed by a one-week inpatient stay. During the inpatient stay, 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
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. AST or 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 Recruiting
New York, New York, United States, 10032
Contact: Gabriela Madera, B.A    212-543-5153      
Contact: Phil Saccone, B.A    212 543-6206      
Principal Investigator: Sandra Comer, Ph.D         
Sponsors and Collaborators
New York State Psychiatric Institute
Omeros Corporation
Investigators
Principal Investigator: Sandra D Comer, MD Columbia University
  More Information

No publications provided

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
Last Updated: November 1, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Oxycodone
Pioglitazone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Hypoglycemic Agents

ClinicalTrials.gov processed this record on July 26, 2014