Concern about abuse/dependence in chronic pain patients taking opioid analgesics may lead
to undertreatment of pain, yet little is known about the prevalence of abuse/dependence in
these patients and how it differs among analgesic agents. The objective of this study was to
assess the prevalence of tramadol abuse compared to nonsteroidal anti-inflammatory drugs
(NSAIDs) and hydrocodone-containing analgesics in patients with chronic noncancer pain
(CNP). The study had three arms. The first arm consisted of subjects prescribed tramadol
alone; the second of subjects randomized to either NSAIDs or tramadol; and the third of
subjects randomized to hydrocodone or tramadol. Each investigator received two boxes of
prescriptions randomized so that one in every four prescriptions was for tramadol. Upon
deciding on the therapeutically appropriate arm, the physician selected the appropriate box,
opened the next envelope and completed the enclosed prescription. After the initial
randomization, physicians could prescribe whatever medication was therapeutically
appropriate. A total of 11,352 subjects were enrolled. Up to nine interviews using
a structured questionnaire were conducted over a 12-month period. An algorithm called the
‘‘Abuse Index’’ was developed to identify subjects who were abusing the drug. The primary
components of the index were increasing dose without physician approval, use for purposes
other than intended, inability to stop its use, and withdrawal.

CiceroJPain2006 2010 feb