Document Detail


A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin® (non-TRF) in prescription opioid abusers.
MedLine Citation:
PMID:  23316699     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: To examine whether tamper-resistant formulations (TRFs) of tapentadol hydrochloride extended-release (ER) 50 mg (TAP50) and tapentadol hydrochloride 250 mg (TAP250) could be converted into forms amenable to intranasal (study 1) or intravenous abuse (study 2).
DESIGN: Randomized, repeated-measures study designs were employed. A non-TRF of OxyContin® 40 mg (OXY40) served as a positive control. No drug was taken in either study.
SETTING: The studies took place in an out-patient setting in New York, NY.
PARTICIPANTS: Twenty-five experienced, healthy ER oxycodone abusers participated in each study.
MEASUREMENTS: The primary outcome for study 1 was the percentage of participants who indicated that they would snort the tampered tablets, while the primary outcome for study 2 was the percentage yield of active drug in solution. Other descriptive variables, such as time spent manipulating the tablets, were also examined to characterize tampering behaviors more clearly.
FINDINGS: Tampered TRF tablets were less desirable than the tampered OXY40 tablets. Few individuals were willing to snort the TRF particles (TAP50: 24%, TAP250: 16%; OXY40: 100% P < 0.001). There was less drug extracted from the TAP50 tablet than from the OXY40 tablet (3.52 versus 37.02%, P = 0.008), and no samples from the TAP250 tablets contained analyzable solutions of the drug. It took participants longer to tamper with the TAPs (study 1: TAP50 versus OXY40, P < 0.01; TAP250 versus OXY40, P < 0.01; study 2: TAP250 versus OXY40, P < 0.05).
CONCLUSIONS: Tamper-resistant formulations of taptentadol (pain relief) tablets do not appear to be well-liked by individuals who tamper regularly with extended-release oxycodone tablets. Employing tamper-resistant technology may be a promising approach towards reducing the abuse potential of tapentadol extended-release.
Authors:
Suzanne K Vosburg; Jermaine D Jones; Jeanne M Manubay; Judy B Ashworth; Douglas Y Shapiro; Sandra D Comer
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2013-03-13
Journal Detail:
Title:  Addiction (Abingdon, England)     Volume:  108     ISSN:  1360-0443     ISO Abbreviation:  Addiction     Publication Date:  2013 Jun 
Date Detail:
Created Date:  2013-05-10     Completed Date:  2013-12-17     Revised Date:  2014-06-03    
Medline Journal Info:
Nlm Unique ID:  9304118     Medline TA:  Addiction     Country:  England    
Other Details:
Languages:  eng     Pagination:  1095-106     Citation Subset:  IM    
Copyright Information:
© 2013 The Authors, Addiction © 2013 Society for the Study of Addiction.
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MeSH Terms
Descriptor/Qualifier:
Adult
Analgesics, Opioid / administration & dosage*,  economics
Chemistry, Pharmaceutical
Drug Packaging
Female
Humans
Male
Middle Aged
Opioid-Related Disorders / economics,  rehabilitation*
Oxycodone / administration & dosage*,  economics
Particle Size
Patient Satisfaction
Phenols / administration & dosage*,  economics
Prescription Drug Misuse / economics,  prevention & control*
Prescription Fees
Tablets
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
K01 DA030446/DA/NIDA NIH HHS; P50 DA009236/DA/NIDA NIH HHS; R01 DA016759/DA/NIDA NIH HHS; R01 DA031022/DA/NIDA NIH HHS; T32 DA007294/DA/NIDA NIH HHS
Chemical
Reg. No./Substance:
0/Analgesics, Opioid; 0/Phenols; 0/Tablets; CD35PMG570/Oxycodone; H8A007M585/tapentadol
Comments/Corrections

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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