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

Phase 2

Completed

• Conditions: Opioid Abuse
• Interventions: Drug: pioglitazone

• Registration Number: NCT01395784
• Lead Sponsor: New York State Psychiatric Institute

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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-07-13
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Status Verified: 2013-11
• Primary Completion: 2014-01
• Study Completion: 2014-04
• Results First Submitted: 2015-08-31
• Results First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Results First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PIO 15 Maintenance Period	pioglitazone	Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg.
Placebo Maintenance Period	pioglitazone	Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB).
PIO 45 Maintenance Period	pioglitazone	Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.

Primary Outcome Measures

Name	Time	Method
Subjective Ratings of "Good" Drug Effect	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 Outcome Measures

Name	Time	Method
Analgesic Responses Using the Cold Pressor Test	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.

Trial Locations

Locations (1)

Columbia Univ/ NYSPI Division on Substance Abuse; 🇺🇸 New York, New York, United States