Prospective studies among patients with known abuse, or at high risk of abuse, reported a tramadol abuse rate, as well as subjective experiences of tramadol withdrawal. A 3-year post-marketing cohort study measured tramadol's nonmedical misuse rates using urine drug testing for tramadol among 1601 participants in 4 US state monitoring programs for impaired healthcare professionals. (7) Tramadol exposure occurred in 140 (8.7%) participants. Thirty-nine (28%) were classified as extensive experimentation or abuse of tramadol. Overall, the rate of extensive experimentation or abuse was 18 cases per thousand person-years. The Hawthorne effect, where awareness of being monitored alters a subject's behavior, may threaten these measured frequency rates' generalizability. Another prospective study assessed the subjective tramadol withdrawal experience in 219 patients with a diagnosis of "Tramadol misuse" who were attending 6 drug detoxification centers in China. (8) Validated drug dependence symptom scales found that while the degree of physical dependence reported was uniformly mild, the majority of patients reported the psychic dependence symptom of tramadol craving.

The FDA's Drug Abuse Advisory Committee performed a formal review of the tramadol abuse evidence in 1998, including the data from Ortho-McNeil's surveillance studies and federal case reporting/surveillance programs. The FDA did not recommend changing tramadol's unscheduled status. (9) The FDA's considered decision to not schedule tramadol as a controlled substance implies its abuse risk to the general population is low in comparison to its novel analgesic benefit.
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