Back to resultsEffects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
Primary Purpose
Opioid Abuse
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
pioglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Abuse focused on measuring Oxycodone, Opioid abuse
Eligibility Criteria
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)
Sites / Locations
- Columbia Univ/ NYSPI Division on Substance Abuse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo Maintenance Period
PIO 15 Maintenance Period
PIO 45 Maintenance Period
Arm Description
Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB).
Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg.
Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.
Outcomes
Primary Outcome Measures
Subjective Ratings of "Good" Drug Effect
Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)
Secondary Outcome Measures
Analgesic Responses Using the Cold Pressor Test
Latency to withdraw hand from cold water during the cold pressor test.
Full Information
NCT ID
NCT01395784
First Posted
July 13, 2011
Last Updated
January 26, 2016
Sponsor
New York State Psychiatric Institute
Collaborators
Omeros Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01395784
Brief Title
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
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Omeros Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Abuse
Keywords
Oxycodone, Opioid abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Maintenance Period
Arm Type
Placebo Comparator
Arm Description
Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB).
Arm Title
PIO 15 Maintenance Period
Arm Type
Experimental
Arm Description
Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg.
Arm Title
PIO 45 Maintenance Period
Arm Type
Experimental
Arm Description
Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective Ratings of "Good" Drug Effect
Description
Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)
Time Frame
Measured during the lab session conducted at the end of each maintenance period
Secondary Outcome Measure Information:
Title
Analgesic Responses Using the Cold Pressor Test
Description
Latency to withdraw hand from cold water during the cold pressor test.
Time Frame
Measured during the lab session conducted at the end of each maintenance period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra D Comer, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia Univ/ NYSPI Division on Substance Abuse
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data has been presented at conferences and being prepared for a peer-review publication.
Learn more about this trial
Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
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