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

NCT ID: NCT01395784

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-04-30

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.

Conditions

Opioid Abuse

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo Maintenance Period

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

Group Type: PLACEBO_COMPARATOR

pioglitazone

Intervention Type: 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.

PIO 15 Maintenance Period

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

Group Type: EXPERIMENTAL

pioglitazone

Intervention Type: 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.

PIO 45 Maintenance Period

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

Group Type: EXPERIMENTAL

pioglitazone

Intervention Type: 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.

Interventions

pioglitazone

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.

Intervention Type: DRUG

Other Intervention Names

Actos

Eligibility 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. 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Omeros Corporation

INDUSTRY

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra D Comer, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia Univ/ NYSPI Division on Substance Abuse

New York, New York, United States

Countries

United States

Other Identifiers

R01DA09236

Identifier Type: OTHER

Identifier Source: secondary_id

6106

Identifier Type: -

Identifier Source: org_study_id