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

NCT01395784 | Completed Phase 2 Results DMC

• 2 other identifiers: 6106R01DA09236
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Abuse

Keywords

Oxycodone; Opioid abuse

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Analgesic Responses Using the Cold Pressor Test

  Measured during the lab session conducted at the end of each maintenance period

Study Arms (3)

Placebo Maintenance Period

PLACEBO COMPARATOR

Participants will complete the various outcome measures following a 2-3 week maintenance period on Placebo (PCB).

Drug: pioglitazone

PIO 15 Maintenance Period

EXPERIMENTAL

Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 15 mg.

Drug: pioglitazone

PIO 45 Maintenance Period

EXPERIMENTAL

Participants will complete the various outcome measures following a 2-3 week maintenance period on Pioglitazone (PIO) 45 mg.

Drug: pioglitazone

Interventions

pioglitazone DRUG

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.

Also known as: Actos

PIO 15 Maintenance Period; PIO 45 Maintenance Period; Placebo Maintenance Period

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Omeros Corporation: collaborator

Study Sites (1)

Columbia Univ/ NYSPI Division on Substance Abuse

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jermaine Jones, PhD
• Organization: New York State Psychiatric Institute

jonesje@nyspi.columbia.edu

646 774-6113

Study Officials

• Sandra D Comer, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 18, 2011
• Study Start: August 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 23, 2016
• Results First Posted: February 23, 2016

Record last verified: 2013-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)