Assessment of Tapentadol API Abuse Liability with the Researched Abuse, Diversion and Addiction-Related Surveillance System

Tapentadol, a Schedule II opioid with a combination of µ-opioid activity and norepinephrine reuptake inhibition, is used for the management of moderate to severe acute and chronic pain. Its dual mechanism of action is thought to reduce opioid-related side effects that can complicate pain management. Since approval, tapentadol has been tracked across multiple outcomes suggesting abuse liability, and a pattern of relatively low, although not absent, abuse liability has been found. This retrospective cohort study further details the abuse liability of tapentadol as an active pharmaceutical ingredient (API) when immediate-release as well as extended-release formulations were on the market together (fourth quarter of 2011 to second quarter of 2016). Tapentadol (API) was compared with tramadol, hydrocodone, morphine, oxycodone, hydromorphone, and oxymorphone across Poison Center, Drug Diversion, and Treatment Center Programs Combined data streams from the Researched Abuse, Diversion and Addiction-Related Surveillance system. Findings suggest the public health burden related to tapentadol to date is low, but present. Event rates of abuse per population-level denominators were significantly lower than all other opioids examined. However, when adjusted for drug availability, event rates of abuse were lower than most Schedule II opioids studied, but were not the lowest. Disentangling these 2 sets of findings further by examining various opioid formulations, such as extended-release and the role of abuse-deterrent formulations, is warranted

Characterizing the Experience of Tapentadol Nonmedical Use: Mixed Methods Study

BackgroundThe prevalence of abuse, diversion, and web-based endorsement of tapentadol (extended-release [ER], immediate-release [IR]) has been characterized as low compared with other prescription opioids. Little is known about individual experience with tapentadol nonmedical use (NMU). ObjectiveThis study aims to pilot web-based survey technologies to investigate the motivation for tapentadol NMU, sources of procurement, routes of administration, tampering methods, doses used, and impressions of tapentadol products (Nucynta and Nucynta ER). MethodsRecruitment flyers and banner advertisements were placed on the Bluelight website [DragonByte Technologies Ltd] with a link to a web-based survey (Qualtrics) designed to query about individuals’ lifetime tapentadol NMU. This web-based survey was followed by an interactive web-based chat (Cryptocat) with respondents who were willing to be contacted. Respondents were queried about sources for obtaining tapentadol, motives for use, routes of administration, tampering methods, drugs used in combination, tablet strengths and dosages, and reasons for continued or discontinued use. Desirability and attractiveness for NMU was rated. ResultsWeb-based recruitment successfully attracted difficult-to-find study participants. A total of 78 participants reported that tapentadol was obtained from friends and family (ER 11/30, 37%; IR 18/67, 27%), the internet (ER 11/30, 37%; IR 12/67, 18%) or participants’ own prescriptions from a doctor (ER 9/30, 30%; IR 17/67, 25%). It was used nonmedically for pain relief (ER 18/30, 60%; IR 33/67, 49%) and multiple psychotropic effects, including relaxation (ER 13/30, 43%; IR 29/67, 43%), reduction in depression or anxiety (ER 7/30, 23%; IR 30/67, 45%), or getting high (ER 12/30, 40%; IR 33/67, 49%). Tapentadol was primarily swallowed (ER 22/30, 73%; IR 55/67, 82%), although snorting (ER 2/30, 7%; IR 8/67, 12%) and injection (ER 2/30, 7%; IR 5/67, 8%) were also reported. The preferred dose for NMU was 100 mg (both ER and IR). The participants reported tapentadol use with benzodiazepines (ER 12/21, 57%; IR 28/47, 60%). Most participants had discontinued tapentadol NMU at the time of survey completion (ER 22/30, 73%; IR 55/67, 82%). Reasons for discontinued ER NMU included side effects (10/22, 46%) and lack of effective treatment (10/22, 46%). Reasons for discontinued IR NMU included lack of access (26/55, 47%) and better NMU options (IR 21/55, 38%). Few individuals were willing to divulge identifying information about themselves for the interactive chat (8/78, 10%), demonstrating the strength of anonymous, web-based surveys. Interactive chat supported the survey findings. A subgroup of participants (4/78, 5%) reported hallucinogenic side effects with high doses. ConclusionsWeb-based surveys can successfully recruit individuals who report drug NMU and those who are difficult to find. Tapentadol NMU appears to occur primarily for pain relief and for its psychotropic effects. Although it was liked by some, tapentadol did not receive a robust pattern of endorsement for NMU