title: A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin® (non-TRF) in prescription opioid abusers.
abstract: OBJECTIVE
  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).
  
  
  METHODS
  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.
  
  
  METHODS
  The studies took place in an out-patient setting in New York, NY.
  
  
  METHODS
  Twenty-five experienced, healthy ER oxycodone abusers participated in each study.
  
  
  METHODS
  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.
  
  
  RESULTS
  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: Division on Substance Abuse, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA. skv2001@columbia.edu
authors: Suzanne K
authors: SK
authors: Vosburg
authors: Jermaine D
authors: JD
authors: Jones
authors: Jeanne M
authors: JM
authors: Manubay
authors: Judy B
authors: JB
authors: Ashworth
authors: Douglas Y
authors: DY
authors: Shapiro
authors: Sandra D
authors: SD
authors: Comer
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000191:economics; D002626:Chemistry, Pharmaceutical; D004349:Drug Packaging; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009293:Opioid-Related Disorders / Q000191:economics / Q000534:rehabilitation*; D010098:Oxycodone / Q000008:administration & dosage* / Q000191:economics; D010316:Particle Size; D017060:Patient Satisfaction; D010636:Phenols / Q000008:administration & dosage* / Q000191:economics; D063487:Prescription Drug Misuse / Q000191:economics / Q000517:prevention & control*; D011306:Prescription Fees; D013607:Tablets; D000077432:Tapentadol; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D010636:Phenols; D013607:Tablets; D010098:Oxycodone; D000077432:Tapentadol