A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin® (non-TRF) in prescription opioid abusers
Article first published online: 13 MAR 2013
© 2013 The Authors, Addiction © 2013 Society for the Study of Addiction
Volume 108, Issue 6, pages 1095–1106, June 2013
How to Cite
Vosburg, S. K., Jones, J. D., Manubay, J. M., Ashworth, J. B., Shapiro, D. Y. and Comer, S. D. (2013), A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin® (non-TRF) in prescription opioid abusers. Addiction, 108: 1095–1106. doi: 10.1111/add.12114
- Issue published online: 10 MAY 2013
- Article first published online: 13 MAR 2013
- Accepted manuscript online: 14 JAN 2013 09:09AM EST
- Manuscript Accepted: 4 JAN 2013
- Manuscript Revised: 9 NOV 2012
- Manuscript Received: 19 SEP 2012
- Johnson and Johnson PRD, LLC
- Abuse deterrent;
- prescription opioids;
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).
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.
The studies took place in an out-patient setting in New York, NY.
Twenty-five experienced, healthy ER oxycodone abusers participated in each study.
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.
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).
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.