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

Opioid Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395784
• Other study ID #: 6106
• Secondary ID: R01DA09236
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2011
• Last updated: January 26, 2016
• Start date: August 2010
• Est. completion date: April 2014

Study information

• Verified date: November 2013
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Abuse

Intervention

Drug:
• pioglitazone
A PPAR? 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.

Locations

Country	Name	City	State
United States	Columbia Univ/ NYSPI Division on Substance Abuse	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Omeros Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Ratings of "Good" Drug Effect	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	No
Secondary	Analgesic Responses Using the Cold Pressor Test	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	No