Evidence map›Paper›PMID 23316699›Full record

Trial reportAddiction (Abingdon, England)2013

A comparison among tapentadol tamper-resistant formulations (TRF) and OxyContin® (non-TRF) in prescription opioid abusers.

Suzanne K Vosburg, Jermaine D Jones, Jeanne M Manubay, Judy B Ashworth, Douglas Y Shapiro, Sandra D Comer

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Addiction (Abingdon, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Article
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  4. Review
  5. Article
  6. Article
  7. Review
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  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Suzanne K VosburgDivision on Substance Abuse, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, USA. skv2001@columbia.edu
Jermaine D Jones
Jeanne M Manubay
Judy B Ashworth
Douglas Y Shapiro
Sandra D Comer

Funding

PHARMACOLOGICAL TREATMENT OF MARIJUANA DEPENDENCEP50DA009236 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI KLEBER, HERBERT DAVID · 1994 to 2013
$39.4M
Translational Clinical Research Fellowship on Substance Use DisordersT32DA007294 · NIDA · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI Frances Rudnick Levin, Diana M Martinez · 1993 to 2026
$9.3M
Prescription Opioid Effects in Drug and Non-drug AbusersR01DA016759 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI COMER, SANDRA D · 2003 to 2014
$5.0M
Pioglitazone for the Treatment of Opioid and of Nicotine DependenceR01DA031022 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI BISAGA, ADAM, COMER, SANDRA D · 2010 to 2013
$3.5M
Contribution of Various Genetic Polymorphisms to Oxycodone's Abuse LiabilityK01DA030446 · NIDA · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI JONES, JERMAINE D · 2011 to 2015
$907k
NIDA NIH HHS K01 DA030446NIDA NIH HHS P50 DA009236NIDA NIH HHS R01 DA016759NIDA NIH HHS R01 DA031022NIDA NIH HHS T32 DA007294
6 · The paper itself

Abstract

aimsTo 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).

designRandomized, 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.

settingThe studies took place in an out-patient setting in New York, NY.

participantsTwenty-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.

findingsTampered 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).

conclusionsTamper-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.

Indexed as

AdultAnalgesics, OpioidChemistry, PharmaceuticalDrug PackagingFemaleHumansMaleMiddle AgedOpioid-Related DisordersOxycodoneParticle SizePatient SatisfactionPhenolsPrescription Drug MisusePrescription FeesTabletsAnalgesics, OpioidOxycodonePhenolsTabletsTapentadol

Identifiers

PMID23316699
PMCPMC3664924

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.