Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)

Risk of Shopping Behavior of Tapentadol IR Immediate-Release (IR) Compared to Oxycodone IR Immediate-Release (IR)

The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate release with the risk of shopping behavior of oxycodone immediate release.

Study Overview

• Status: Completed
• Conditions: Substance Abuse Detection
• Intervention / Treatment: Drug: Tapentadol IR; Drug: Oxycodone IR

Detailed Description

This is a retrospective (a study that looks backward in time, usually using medical records and interviews with patients) matched cohort (designated group followed or traced over a period of time) study using IMS LRx database. This database covers 65% of all retail prescriptions in the United States and includes mail service and specialty pharmacy provider prescriptions independent of the method of payment. The study will include Opioid naive patients exposed to tapentadol immediate release (IR) or oxycodone IR from July 2009 to December 2010. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. Patients will be followed for 1 year from their index dates. Each tapentadol IR-exposed patient will be matched to up to 4 oxycodone IR-exposed patients. Matching will allow to control in the design for potential confounding variables such as time of the exposure, geographic area, specialty of the prescriber, and age. These are variables that have been related with the risk of shopping behavior or abuse.

• Study Type: Observational
• Enrollment (Actual): 646620

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Opioid naive patients exposed to tapentadol IR or oxycodone IR from July 2009 to December 2010 who did not fill any other opioid prescription within 4 days on or after the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date.

Description

Inclusion Criteria:

• Opioid naive patients (a patient who has not received an opioid of any type in the 3 months before the index date) exposed to tapentadol IR or oxycodone IR from July 2009 to December 2010 [The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009]

Exclusion Criteria:

• Patients with use of any opioid 3 months before the index date
• Patients who within 4 days on or after the index date fill a prescription for a different opioid
• Patients who within 4 days on or after the index date fill a prescription for the same opioid but written by a different prescriber

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tapentadol IR	Drug: Tapentadol IR; Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
Oxycodone IR	Drug: Oxycodone IR; Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who developed shopping behavior defined as patients with prescriptions with at least one day of overlap, written by ≥ 2 different prescribers and filled in 3 or more pharmacies	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first episode of shopping behavior		12 months
The number of shopping episodes during the year of follow up		12 months
The type of dispensing in the first episode of shopping event	The type of dispensing in the shopping event will be classified as "Only the indexed opioid" "Indexed opioid was involved", or "Indexed opioid was not involved at all".	12 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Investigators: Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General Publications

• Cepeda MS, Fife D, Vo L, Mastrogiovanni G, Yuan Y. Comparison of opioid doctor shopping for tapentadol and oxycodone: a cohort study. J Pain. 2013 Feb;14(2):158-64. doi: 10.1016/j.jpain.2012.10.012. Epub 2012 Dec 17.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2012
• Last Update Submitted That Met QC Criteria: October 26, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Substance abuse detection; Opioids abuse; Tapentadol immediate-release (IR); Oxycodone immediate-release (IR)
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Adrenergic Uptake Inhibitors; Oxycodone; Tapentadol
• Other Study ID Numbers: CR100822; RRA-5950 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)