Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Abuse |
Drug: pioglitazone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effects of Pioglitazone, a PPARgamma Receptor Agonist, on the Abuse Liability of Oxycodone |
- Subjective ratings of drug, mood, and physiological effects [ Time Frame: Repeatedly during the 9-week study ] [ Designated as safety issue: No ]Visual analog scale ratings (0-100 mm scale, 0=Not at all, 100=Extremely)
- Analgesic responses using the cold pressor test [ Time Frame: Repeatedly over the 9-week study ] [ Designated as safety issue: No ]Latency to first feel pain (in sec) and latency to remove the hand from the water (in sec) are the primary analgesic endpoints.
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Withing-subjects, Placebo-Controlled |
Drug: pioglitazone
A PPARγ agonist, also marketed as Actos.
Other Name: Actos
|
Detailed Description:
This 9-week investigation will use an inpatient/outpatient design in which participants (N=20 completers) will be maintained on ascending doses of pioglitazone (3 weeks on placebo followed by 3 weeks on 15 mg followed by 3 weeks on 45 mg). For each dose, 2 weeks of stabilization will occur on an outpatient basis, followed by a one-week inpatient stay. During the inpatient stay, the effects of oxycodone (0, 10, and 20 mg) will be examined during a single laboratory session using a cumulative dosing procedure.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
- AST or 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)
Contacts and Locations| United States, New York | |
| Columbia Univ/ NYSPI Division on Substance Abuse | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Gabriela Madera, B.A 212-543-5153 | |
| Contact: Phil Saccone, B.A 212 543-6206 | |
| Principal Investigator: Sandra Comer, Ph.D | |
| Principal Investigator: | Sandra D Comer, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01395784 History of Changes |
| Other Study ID Numbers: | 6106, R01DA09236 |
| Study First Received: | July 13, 2011 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York State Psychiatric Institute:
|
Oxycodone Opioid abuse |
Additional relevant MeSH terms:
|
Substance-Related Disorders Mental Disorders Oxycodone Pioglitazone Narcotics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid Hypoglycemic Agents |
ClinicalTrials.gov processed this record on May 23, 2013